BIAFINE

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

LABORATOIRE MEDIX

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

Pre-market Notification Details

• Device ID: K943910
• 510k Number: K943910
• Device Name: BIAFINE
• Classification: Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
• Applicant: LABORATOIRE MEDIX 18 RUE SAINT MATHIEU Houdan, FR 78550
• Contact: Jean Pierre
• Correspondent: Jean Pierre; LABORATOIRE MEDIX 18 RUE SAINT MATHIEU Houdan, FR 78550
• Product Code: MGQ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-11
• Decision Date: 1995-02-27