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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 K033258
Device Name BONESAVE BONE VOID FILLER
Applicant
Howmedica Osteonics
59 Rte. 17
Allendale,  NJ  07401
Applicant Contact LORRAINE MONTEMURRO
Correspondent
Howmedica Osteonics
59 Rte. 17
Allendale,  NJ  07401
Correspondent Contact LORRAINE MONTEMURRO
Regulation Number888.3045
Classification Product Code
MQV  
Date Received10/09/2003
Decision Date 03/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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