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FDA 510(k) Application Details - K092608
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K092608
Device Name
Filler, Bone Void, Calcium Compound
Applicant
COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES, NJ 07417 US
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Contact
PEGGY HANSEN
Other 510(k) Applications for this Contact
Regulation Number
888.3045
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Classification Product Code
MQV
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More FDA Info for this Product Code
Date Received
08/25/2009
Decision Date
05/28/2010
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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