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FDA 510(k) Application Details - K113836
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K113836
Device Name
Dressing, Wound, Drug
Applicant
AVERY DENNISON BELGIE, BVBA
20N. WACKER DRIVE
SUITE 2240
CHICAGO, IL 60606 US
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Contact
JERZY WOJCIK
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
12/28/2011
Decision Date
09/24/2012
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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