FDA 510(k) Application Details - K992416

Device Classification Name Bone Grafting Material, Synthetic

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510(K) Number K992416
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 07/20/1999
Decision Date 10/15/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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