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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
510(k) Number K915445
Device Name MAALEABLE FACIAL IMPLANT
Applicant
Biomet Ussc Orthopedics
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact MARY VERSTYNEN
Correspondent
Biomet Ussc Orthopedics
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact MARY VERSTYNEN
Regulation Number878.3500
Classification Product Code
KKY  
Date Received12/05/1991
Decision Date 02/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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