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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, Osteoinduction (W/O Human Growth Factor)
510(k) Number K051195
Device Name GRAFTON DBM
Applicant
Osteotech, Inc.
51 James Way
Eatontown,  NJ  07724
Applicant Contact CHRISTOPHER W TALBOT
Correspondent
Osteotech, Inc.
51 James Way
Eatontown,  NJ  07724
Correspondent Contact CHRISTOPHER W TALBOT
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received05/10/2005
Decision Date 12/16/2005
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
Recalls CDRH Recalls
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