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Ann: AIR FDA 510K Filed and New US Distribution, page-3

  1. salston
    105 Posts.
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    28/04/22
    11:21
    Post #: 61066836
    Mr Google gave me an answer - should have gone there first!

    Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.
    UCM Price at posting: 8.7¢ Sentiment: Hold Disclosure: Held
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    lightbulb Created with Sketch.  Great analysis
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