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What does 510(k) mean?

Databases A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device...

What is the FDA 510(k) database?

What You Need to Know about FDA 510 (k) Database The U.S. Food and Drug Administration established the FDA database for 510 (k) clearances to serve as a repository for classification information about medical devices that have been cleared by the agency under the premarket notification process or what’s known as 510 (k) process.

How do I search the releasable 510(k) database?

You can search the releasable 510 (k) database by Panel, 510 (k) number, Product code or Device name. A search query will produce information from the database in the following format:

What is PMN ( premarket notification) or 510(k)?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).


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