FDA 510(k) Application Details - K063676

Device Classification Name Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

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510(K) Number K063676
Device Name Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Applicant MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 MAY STREET
EDISON, NJ 08837 US
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Contact NANCY BENNEWITZ
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Regulation Number 888.3045

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Classification Product Code MBP
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Date Received 12/11/2006
Decision Date 03/05/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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