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NickHous

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NickHous

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Monday, 12/18/2017 12:44:47 PM

Monday, December 18, 2017 12:44:47 PM

Post# of 10345
Copied and pasted below from 510k submittal procedures, etc. Below is what sticks out to me. ARTH has to start all over. Read also where the submitter should have been at least 30 days away from being able to manufacture (this was from other search regarding recommendations for successful 510k submittal) I don't think they have the manufacturing capability at all!


the submission will be considered withdrawn and deleted from our review system. If the 510(k) is deleted, the 510(k) submitter will need to submit a new 510(k) to pursue FDA marketing clearance for that device.
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