FDA 510(k) Application Details - K030288

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K030288
Device Name Filler, Bone Void, Calcium Compound
Applicant OSTEOBIOLOGICS, INC.
UNIVERSITY BUSINESS PARK
12500 NETWORK, SUITE 112
SAN ANTONIO, TX 78249-3308 US
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Contact GABRIELE G NEIDERAUER
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 01/28/2003
Decision Date 07/17/2003
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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