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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 K190342
Device Name BIAFINE Topical Cream
Applicant
Bausch Health Americas Incorporated
1400 N. Goodman St. 14609 Usa
Rochester,  NY  14609
Applicant Contact Marci Halevi
Correspondent
Bausch Health Americas Incorporated
1400 N. Goodman St. 14609 Usa
Rochester,  NY  14609
Correspondent Contact Marci Halevi
Classification Product Code
FRO  
Date Received02/14/2019
Decision Date 10/18/2019
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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