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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K173549
Device Name BIAFINE
Applicant
Valeant Pharmaceuticals
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact Melissa Thomas
Correspondent
Valeant Pharmaceuticals
400 Somerset Corporate Blvd.
Bridgewater,  NJ  08807
Correspondent Contact Marci Halevi
Classification Product Code
FRO  
Date Received11/16/2017
Decision Date 08/13/2018
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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