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FDA 510(k) Application Details - K113807
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K113807
Device Name
Dressing, Wound, Drug
Applicant
PIERRE FABRE MEDICAL DEVICES
1129 TWENTIETH ST., NW
SUITE 600
WASHINGTON, DC 20036 US
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Contact
DIANE MANDELL HORWITZ
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
12/23/2011
Decision Date
03/07/2012
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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