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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K943910
Device Name BIAFINE
Applicant
Laboratoire Medix
18 Rue Saint Mathieu
Houdan,  FR 78550
Applicant Contact JEAN PIERRE
Correspondent
Laboratoire Medix
18 Rue Saint Mathieu
Houdan,  FR 78550
Correspondent Contact JEAN PIERRE
Classification Product Code
MGQ  
Date Received08/11/1994
Decision Date 02/27/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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