BIAFINE Topical Cream

Dressing, Wound, Drug

Bausch Health Americas Incorporated

The following data is part of a premarket notification filed by Bausch Health Americas Incorporated with the FDA for Biafine Topical Cream.

Pre-market Notification Details

Device IDK190342
510k NumberK190342
Device Name:BIAFINE Topical Cream
ClassificationDressing, Wound, Drug
Applicant Bausch Health Americas Incorporated 1400 N. Goodman St. 14609 USA Rochester,  NY  14609
ContactMarci Halevi
CorrespondentMarci Halevi
Bausch Health Americas Incorporated 1400 N. Goodman St. 14609 USA Rochester,  NY  14609
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-02-14
Decision Date2019-10-18

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