BIAFINE

Dressing, Wound, Drug

Valeant Pharmaceuticals

The following data is part of a premarket notification filed by Valeant Pharmaceuticals with the FDA for Biafine.

Pre-market Notification Details

• Device ID: K173549
• 510k Number: K173549
• Device Name: BIAFINE
• Classification: Dressing, Wound, Drug
• Applicant: Valeant Pharmaceuticals 1400 North Goodman Street Rochester, NY 14609
• Contact: Melissa Thomas
• Correspondent: Marci Halevi; Valeant Pharmaceuticals 400 Somerset Corporate Boulevard Bridgewater, NJ 08807
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2017-11-16
• Decision Date: 2018-08-13
• Summary: summary