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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 K082615
Device Name GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
Applicant
OSTEOTECH INC
51 JAMES WAY
EATONTOWN,  NJ  07724
Applicant Contact CHRIS TALBOT
Correspondent
OSTEOTECH INC
51 JAMES WAY
EATONTOWN,  NJ  07724
Correspondent Contact CHRIS TALBOT
Regulation Number888.3045
Classification Product Code
MQV  
Date Received09/09/2008
Decision Date 10/16/2008
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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