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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 K060408
Device Name NORIAN SRS BONE VOID FILLER
Original Applicant
SYNTHES (USA)
1230 wilson drive
west chester,  PA  19380
Original Contact angela j silvestri
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/16/2006
Decision Date 03/21/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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