Some light reading re. the FDA 510(k) submission process we are...

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    Some light reading re. the FDA 510(k) submission process we are currently going through. It looks like we are going to have a fair idea within 60 days if we are getting clearance - with final clearance due within 90 days.

    https://hotcopper.com.au/data/attachments/4468/4468086-11839f0944b7a84b9e04858b59bda81d.jpg

    https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process?source=govdelivery&utm_medium=email&utm_source=govdelivery

 
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