FDA 510(k) Application Details - K022622

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K022622
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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Contact FRANCOIS GENIN
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 08/07/2002
Decision Date 01/09/2003
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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