How to prepare a 510k submission for FDA

MedicalMarcom 12,648 lượt xem 9 years ago

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http://medgroup.biz/510k-tips for the slides and transcript.

Rob Packard is THE MAN when it comes to helping medical device companies submit 510k applications.

medical device

medical devices

510k submissions

510(k) applications FDA

FDA clearance 510k

510k versus de novo

510k vs PMA

Food And Drug Administration (Government Agency)

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