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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
510(k) Number K962913
Device Name SYNTHES STERILE DRILL BITS
Applicant
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI,  PA  19301 -1222
Applicant Contact ANGELA J SILVESTRI
Correspondent
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI,  PA  19301 -1222
Correspondent Contact ANGELA J SILVESTRI
Regulation Number878.4820
Classification Product Code
HWE  
Subsequent Product Codes
GFA   GFF   HSZ  
Date Received07/26/1996
Decision Date 11/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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