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510(k) K190342

BIAFINE Topical Cream by Bausch Health Americas Incorporated — Product Code FRO

K190342 is an FDA 510(k) premarket notification submitted by Bausch Health Americas Incorporated for the device "BIAFINE Topical Cream". The FDA issued a decision of Substantially Equivalent on Oct 18, 2019. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 18, 2019
Date Received
Feb 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

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FDA data resources