FDA 510(k) Application Details - DEN150029

Device Classification Name

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510(K) Number DEN150029
Device Name Permaseal
Applicant MICRO INTERVENTIONAL DEVICES, INC.
5 CAUFIELD PL. SUITE 102
NEWTOWN, PA 18940 US
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Contact LINDA MORGAN
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Regulation Number

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Classification Product Code PNQ
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Date Received 06/22/2015
Decision Date 07/27/2016
Decision DENG -
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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