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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 K031435
FOIA Releasable 510(k) K031435
Device Name BONESOURCE BVF
Applicant
Howmedica Osteonics
59 Rte. 17
Allendale,  NJ  07401
Applicant Contact DEBRA BING
Correspondent
Howmedica Osteonics
59 Rte. 17
Allendale,  NJ  07401
Correspondent Contact DEBRA BING
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/06/2003
Decision Date 08/04/2003
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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