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Sunday, July 22, 2018 12:43:42 PM
If no questions from FDA on 510K by 12 Sep, we should be setting sale soon after with full clearance. FDA has the right to ask questions within 60 days of submission. Unfortunately, when they do ask a question, the clock resets once the answer is provided. I figure this will b ironed out by December, as nothing with the GOV is ever fast.
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