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FDA 510(k) Application Details - K173549
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K173549
Device Name
Dressing, Wound, Drug
Applicant
Valeant Pharmaceuticals
1400 North Goodman Street
Rochester, NY 14609 US
Other 510(k) Applications for this Company
Contact
Melissa Thomas
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
11/16/2017
Decision Date
08/13/2018
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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