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FDA 510(k) Application Details - K122817
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K122817
Device Name
Dressing, Wound, Drug
Applicant
ARGENTUM MEDICAL, LLC.
810 LANDMARK DRIVE
SUITE 126
GLEN BURNIE, MD 21061 US
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Contact
WALT BRITTLE
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
09/14/2012
Decision Date
05/01/2014
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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