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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 K042125
Device Name AFT
Applicant
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 MAY STREET
EDISON,  NJ  08837
Applicant Contact KAREN HARDWICK
Correspondent
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 MAY STREET
EDISON,  NJ  08837
Correspondent Contact KAREN HARDWICK
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/06/2004
Decision Date 07/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
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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