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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 K952922
Device Name BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL
Applicant
Orthovita Co.
212 Carnigie Center Dr.
Suite 206
Princeton,  NJ  08540
Applicant Contact THOMAS BECZE
Correspondent
Orthovita Co.
212 Carnigie Center Dr.
Suite 206
Princeton,  NJ  08540
Correspondent Contact THOMAS BECZE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received06/26/1995
Decision Date 12/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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