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FDA 510(k) Application Details - K103795
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K103795
Device Name
Filler, Bone Void, Calcium Compound
Applicant
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 MAY STREET
EDISON, NJ 08837 US
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Contact
NANCY JOY
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
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More FDA Info for this Product Code
Date Received
12/27/2010
Decision Date
04/13/2011
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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