FDA 510(k) Application Details - K000149

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K000149
Device Name Bone Grafting Material, Synthetic
Applicant U.S. BIOMATERIALS CORP.
ONE PROGRESS BLVD.
ALACHUA, FL 32615 US
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Contact ALBERT FOSMOE
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Regulation Number 872.3930

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Classification Product Code LYC
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Date Received 01/19/2000
Decision Date 02/07/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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