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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 K904111
Device Name HTR POLYMER, HTR-MX
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact DAVID S JOHNSON
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact DAVID S JOHNSON
Regulation Number878.3500
Classification Product Code
KKY  
Date Received09/06/1990
Decision Date 11/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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