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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 K924935
Device Name HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
Applicant
Polyclinic Medical Center
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact MARY L VERSTYNEN
Correspondent
Polyclinic Medical Center
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact MARY L VERSTYNEN
Regulation Number878.3500
Classification Product Code
KKY  
Subsequent Product Codes
FWP   FZE   LZK  
Date Received09/30/1992
Decision Date 09/02/1993
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
Recalls CDRH Recalls
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