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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 K042707
Device Name GRAFTON PLUS DBM PASTE
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 Received09/30/2004
Decision Date 11/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
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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