Dear Forum,

I´m have been searching the FDA´s website for some time now looking for a specific summary of a 510(k) dating back to the 1980s. I can find the product, the 510(k) number, though no link to the summary (with the indications for use, which is what I need...).

Does anyone know if it is possible to obtain a summary somewhere? I searched the whole FDA site for this 510(k) number without luck. Is it too old for appearing with summary?

Not sure about FDA´s practice here.

best regards
t.

try this link http://www.foiservices.com/......you may find what you are looking for.....

If you still couldn't find...let me know what device you're exactly looking for....so that I can help you.

Thanks for the links, though I didn´t find the summary I was looking for.

The paper I´m looking for is the summary of 510(k) # K802146 for the product Aquasonic 100 (sterile ultrasound gel).



regards
t.

Thanks for the links, though I didn´t find the summary I was looking for.

The paper I´m looking for is the summary of 510(k) # K802146 for the product Aquasonic 100 (sterile ultrasound gel).

regards
t.

Is it this (http://www.fda.gov/cdrh/pdf7/K072515.pdf) you're looking for?

Or this (http://www.fda.gov/cdrh/pdf3/K030889.pdf)?

Stijloor.

Thanks Stijloor,
I found the same two documents on the FDA site. The device I´m looking for appears as the predicate in these two documents, though I did not manage to get hold on the 510(k) for the predicate itself.

Did anyone try to contact FDA directly on such matters? Do they normally give you such documentation?

regards
t.

Thanks Stijloor,
I found the same two documents on the FDA site. The device I´m looking for appears as the predicate in these two documents, though I did not manage to get hold on the 510(k) for the predicate itself.

Did anyone try to contact FDA directly on such matters? Do they normally give you such documentation?

regards
t.You can get it under FOIA (http://www.fda.gov/opacom/backgrounders/foiahand.html), but it takes a long time (18 months or more). There are services that can get it for you faster (http://www.foiservices.com/) for a premium.