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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 K060161
Device Name AFT ALLOGRAFT FILLER TUBE
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  
Date Received01/20/2006
Decision Date 03/21/2006
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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