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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 K934861
Device Name HARD TISSUE REPLACEMENT (HTR) GRANULAR
Applicant
Poly-Medics,Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact MARY L VERSTYNEN
Correspondent
Poly-Medics,Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact MARY L VERSTYNEN
Regulation Number878.3500
Classification Product Code
KKY  
Date Received10/12/1993
Decision Date 11/04/1994
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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