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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
Recalls CDRH Recalls
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