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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K002362
Device Name SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
Applicant
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI,  PA  19301 -1222
Applicant Contact BONNIE J SMITH
Correspondent
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI,  PA  19301 -1222
Correspondent Contact BONNIE J SMITH
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/03/2000
Decision Date 11/01/2000
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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