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FDA 510(k) Application Details - DEN150029
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PNQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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