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510(k) K173549

BIAFINE by Valeant Pharmaceuticals — Product Code FRO

K173549 is an FDA 510(k) premarket notification submitted by Valeant Pharmaceuticals for the device "BIAFINE". The FDA issued a decision of Substantially Equivalent on August 13, 2018. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2018
Date Received
November 16, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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FDA data resources