510(k) is a premarket technical document submitted..

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510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc. https://www.proregulations.com..../u-s-medical-device-

U.S. Medical Device 510(k) Premarket Notification - Proregulations

Proregulations provides a range of U.S. medical device 510(k) premarket notification services to help customers reach their goal of selling in the U.S. market as quickly as possible.

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U.S. Medical Device 510(k) Premarket Notification - Proregulations

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