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- 2022-11-01 发布于四川
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Contains Nonbinding Recommendations
Refuse to Accept Policy for
510(k)s
Guidance for Industry and Food
and Drug Administration Staff
Document issued on: December 31, 2012
This document supersedes Center for Devices and Radiological Health’s
Premarket Notification (510(k)) Refuse to Accept Policy, dated June 30, 1993,
and 510(k) Refuse to Accept Procedures (K94-1) blue book memo, dated May
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