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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 K941780
Device Name ORTHOVITA BIOGRAN
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 Received04/15/1994
Decision Date 02/10/1995
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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