Keyword Analysis & Research: types of 510k


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When do you need a 510k?

If you are planning to manufacture or distribute a medical device within the United States of America, the FDA requires (in most cases) that you complete either a 510k submission or obtain premarket approval for your medical device.

What is a traditional 510 k?

Introduction. A 510 (k) is a document containing information required under 21 CFR 807 Subpart E. All 510 (k)s are based on the concept of substantial equivalence (SE) to a legally marketed (predicate) device. All 510 (k)s provide a comparison between the device to be marketed and the predicate device or devices.


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