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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Human Source
510(k) Number K051188
FOIA Releasable 510(k) K051188
Device Name GRAFTON DBM
Applicant
OSTEOTECH, INC.
51 JAMES WAY
EATONTOWN,  NJ  07724
Applicant Contact CHRISTOPHER TALBOT
Correspondent
OSTEOTECH, INC.
51 JAMES WAY
EATONTOWN,  NJ  07724
Correspondent Contact CHRISTOPHER TALBOT
Regulation Number872.3930
Classification Product Code
NUN  
Date Received05/10/2005
Decision Date 01/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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