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FDA 510(k) Application Details - K092348
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K092348
Device Name
Dressing, Wound, Drug
Applicant
POLYREMEDY, INC.
24372 MCCLOUD COURT
LAGUNA NIGUEL, CA 92677 US
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Contact
GARY MOCNIK
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2009
Decision Date
04/08/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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