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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 K063676
Device Name DBX DEMINERALIZED BONE MATRIX MIX
Applicant
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 MAY STREET
EDISON,  NJ  08837
Applicant Contact NANCY BENNEWITZ
Correspondent
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 MAY STREET
EDISON,  NJ  08837
Correspondent Contact NANCY BENNEWITZ
Regulation Number888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received12/11/2006
Decision Date 03/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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