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FDA 510(k) Application Details - K040405
Device Classification Name
Filler, Bone Void, Calcium Compound
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510(K) Number
K040405
Device Name
Filler, Bone Void, Calcium Compound
Applicant
BERKELEY ADVANCED BIOMATERIALS, INC.
1933 DAVIS ST. SUITE 307
SAN LEANDRO, CA 94577 US
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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
02/17/2004
Decision Date
03/05/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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