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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K000149
Device Name NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
Applicant
Usbiomaterials Corp.
One Progress Blvd.
Alachua,  FL  32615
Applicant Contact ALBERT FOSMOE
Correspondent
Usbiomaterials Corp.
One Progress Blvd.
Alachua,  FL  32615
Correspondent Contact ALBERT FOSMOE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/19/2000
Decision Date 02/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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