Locating Approved Special 510(k) Submission Data from 1997

I just started a new job, and my supervisor has just resigned and so now I need to started a special 510k listing. Our device was approved in 1997, and I was hoping to find the data we submitted for that device on the FDA website. Does anyone know if/how I can access approved 510k submission on the fda website?

You will not find this information on the website. With a clearance date of 1997 you may not find much at all as some of the info may have been purged from the website.

The obvious question is why doesn't your company have a copy of your oiginal 510(k)?

Generally the only recourse is to go through a Freedom of Information request. This however costs a modest fee, but worse than that takes months, if not years to work through the process.

If this is indeed your 510(k) and you can prove it, perhaps the FDA could give you a non-redacted copy that is not subject to FOI. you would need to contact them to see if it would work.

Finally, perhaps its just the wording, but a special 510(k) is not a listing. It is a product submission, subject to review and clearance by CDRH.

Good luck.
RA Guy

Thanks. I was hoping the information would be easily available on line so I could avoid going down to the archives!

I am going to start the 510k submission, so there may be more questions/advice/help coming, since this will be my first one. Thanks for the good luck!