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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 K962616
Device Name SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
Original Applicant
SYNTHES (USA)
1690 russell rd.
post office box 1766
paoli,  PA  19301
Original Contact angela j silvestri
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/03/1996
Decision Date 09/03/1996
Decision substantially equivalent for some indications (SN)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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