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FDA 510(k) Application Details - K053213
Device Classification Name
Filler, Bone Void, Calcium Compound
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510(K) Number
K053213
Device Name
Filler, Bone Void, Calcium Compound
Applicant
BERKELEY ADVANCED BIOMATERIALS, INC.
901 GRAYSON ST., SUITE 101
BERKELEY, CA 94710 US
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Contact
FRANCOIS GENIN
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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
11/16/2005
Decision Date
07/06/2006
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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