Does anyone here know what this is?

[Sundog]

Do not go use google or any other search engine!!! I want to see if anyone knows what this is offhand. I am working on one tonight.

Does anyone know what a 510(k) is?



Post your answer/guess.

 

[Kalvin00]

It's a 401(k) and a 109(k) sandwiched together.

 

[minendo]

Has to deal with the FDA. That is as much as I know. We briefly discussed it in our Food Analysis course.

 

[arcenite]

uh... 510,000 of something..?

Bill

 

[Sundog]

Originally posted by: minendo
Has to deal with the FDA. That is as much as I know. We briefly discussed it in our Food Analysis course.

On the right track.

Originally posted by: Kalvin00
It's a 401(k) and a 109(k) sandwiched together.

lol

 

[Ness]

I remember it has something to do with medicine. I don't know anything else though I lose.

 

[idNut]

Where you at now without Google?

 

[Rage187]

i'm guessing something about investing in pharmacutical companys?

 

[Evadman]

Originally posted by: minendo
Has to deal with the FDA. That is as much as I know. We briefly discussed it in our Food Analysis course.

I think it is a requirement for FDA clearance or something like that. I remember it from buying some biomedical stocks.

 

[Sundog]

Originally posted by: idNut
Where you at now without Google?

I am saying don't use google to find the answer.

 

[iwearnosox]

Is it where medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected?

 

[Sundog]

Originally posted by: Evadman

Originally posted by: minendo
Has to deal with the FDA. That is as much as I know. We briefly discussed it in our Food Analysis course.

I think it is a requirement for FDA clearance or something like that. I remember it from buying some biomedical stocks.

Bingo. And you used the correct terminology (clearance)!:Q I am impressed. Most think it is an approval by the FDA, but that would be a PMA.

A 510(k) is an FDA clearance to market a product (in this case a medical device) that is found substantially equivalent to another product currently on the market.

 

[Evadman]

Originally posted by: iwearnosox
Is it where medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected?

Originally posted by: Sundog
Do not go use google or any other search engine!!!

Guess comprehension is not your strong suit is it iwearnosox

 

[iwearnosox]

Originally posted by: Evadman

Originally posted by: iwearnosox
Is it where medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected?

Originally posted by: Sundog
Do not go use google or any other search engine!!!

Guess comprehension is not your strong suit is it iwearnosox

And you apparently own no humor suit.

 

[Sundog]

Originally posted by: iwearnosox
Is it where medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected?

Yeppers...and you too are a true nerd if that was from your memory !

 

[Evadman]

Originally posted by: Sundog
...:Q I am impressed....
A 510(k) is an FDA clearance to market a product (in this case a medical device)

Don't be. I thought it was for a medical drug, not device. *shrugs* I just got lucky

 

[Sundog]

Originally posted by: Evadman

Originally posted by: Sundog
...:Q I am impressed....
A 510(k) is an FDA clearance to market a product (in this case a medical device)

Don't be. I thought it was for a medical drug, not device. *shrugs* I just got lucky

The word clearance is crucial though. Many companies incur fines for using the word approved in advertising when they submitted a 510(k) and not a PMA (PreMarket Approval).

 

[Evadman]

Originally posted by: iwearnosox
And you apparently own no humor suit.

Hehe, your first post before you edited it (you edited it just before I quoted you. ) said this:

Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code.

So either it was copied off a web page, or you had a handy dandy database that you built on your machine for searching 510(k)'s, and wrote yourself instructions on how to use it.



hehe, found the paragraph using Google

x 2
hehe

 

[Evadman]

So are you writing a proposal for one of these Sundog? Or do you work for the FDA and you grant these?

 

[iwearnosox]

Originally posted by: Evadman

Originally posted by: iwearnosox
And you apparently own no humor suit.

Hehe, your first post before you edited it (you edited it just before I quoted you. ) said this:

Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code.

So either it was copied off a web page, or you had a handy dandy database that you built on your machine for searching 510(k)'s, and wrote yourself instructions on how to use it.



hehe, found the paragraph using Google

x 2
hehe

That's my 501k site, glad you visited it!

 

[Evadman]

Originally posted by: iwearnosox
That's my 501k site, glad you visited it!

Sweet! 3/4 of what I read on that page went over my head. I will have to remember to ask you to explain it later

 

[Sundog]

Originally posted by: Evadman
So are you writing a proposal for one of these Sundog? Or do you work for the FDA and you grant these?

I am preparing a 510(k) to submit to the FDA by the end of the week.

 

[Hayabusa Rider]

Also a potentially useful investment tool perhaps?