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Re: OldYankee post# 7022

Monday, 09/26/2016 5:55:20 PM

Monday, September 26, 2016 5:55:20 PM

Post# of 40881
Technicality speaking Acceptance Review is the first 15 days so Substantive review is 45 days.

What are your thoughts on the following?

http://charts.stocktwits.com/production/original_5133479.?1474926616

Damn I just found this:

A 510(k) Summary or 510(k) Statement must be included in your 510(k) submission in order for FDA to begin its scientific review of the 510(k) submission. The choice between the 510(k) Summary and 510(k) Statement should be made before the 510(k) is submitted. You may elect to change your choice between the summary or statement BEFORE the substantial equivalence determination is reached. However, after this determination is made, you cannot change your choice of a 510(k) Summary or 510(k) Statement.


510(k) Summary or Statement

You are right OldYankee, Summary Characteristics are part of the scientific review. Hopefully previous review is factored in and just the summary is reviewed!
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