Don Kloos As Joanne pointed out, go to the FDA database and look. Depending on how the company filed, you may even be able to request a copy of it in writing, and they have to comply.

Initiate a request for the 510(k) you are interested in per the FOIA - Freedom of Information Act, through the Division of Information Disclosure (DID), Office of Communication and Education (OCE), Center for Devices and Radiological Health (CDRH). Food and Drug Administration (FDA),.

Robert J Bard, JD, CQE, RAC Rick, as Joanne has provided, the FDA 510k database is one of the best sources of a predicate devices. Download the 510k Summary that the FDA posts; although it is only a summary, it can help identify some the submission needs. Be very careful of the information in the summary and any FOI 510k you may obtain. The Agency's requirements for supporting data changes very fast and all submissions new to be based on recent/current requirements (regulation and guidance documents). Make sure that you review the associated regulation for your predicate and that your device fits. Make sure you limit your submission to a single or primary predicate.

As for full 510k, FOI Services is a commercial operation and can be helpful if they have the specific k number you are looking on hand. If FOI Services does not have a copy already on hand, they can order it or you as Anil has suggest. Just know that if you have to order a copy of the 510k from the Federal Government, you should plan for a year or more wait...not very fast but it will come eventually.

Also, as Don pointed out, you may have the right to request a copy from the 510k holder if they did not submit a 510k Summary with their 510k submission. Only submitter that did not submit a Summary are required by law to provide a copy of their "whole" 510k submission (minus proprietary information/trade secrets).

If you have additional questions, send an email (rbard@reglaw.net).

Good luck on your submission,

Bob