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FDA 510(k) Application Details - K090141
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K090141
Device Name
Dressing, Wound, Drug
Applicant
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN, PA 18109-9341 US
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Contact
LISA GIAQUINTO
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
01/21/2009
Decision Date
03/17/2009
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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