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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K963798
Device Name SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI,  PA  19301
Applicant Contact ANGELA SILVESTRI
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI,  PA  19301
Correspondent Contact ANGELA SILVESTRI
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/23/1996
Decision Date 11/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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