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FDA 510(k) Application Details - K122634
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K122634
Device Name
Dressing, Wound, Drug
Applicant
PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC
150 LEVINBERG LANE
WAYNE, NJ 07470 US
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Contact
MASON DIAMOND
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Regulation Number
000.0000
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Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
08/29/2012
Decision Date
03/12/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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