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Does anyone have any insight as to why Appendix C. 510(k) Process diagram was taken out of the most recent Draft Guidance that was issued on July 28, 2014? In the Draft Guidance that was issued on July 28, 2014, Appendix C. is Sample of 510(k) Summary Complying with 21CFR 807.92.
Attachments
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FDA Guidance 28Jul2014 - The 510K Program- Evaluating Substantial Equivalence in 510k Submission.pdf592.7 KB Views: 168
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356.6 KB Views: 172