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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 K852682
Device Name CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG
Applicant
Calcitek, Inc.
4125-B Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact RICHARD HUNTER
Correspondent
Calcitek, Inc.
4125-B Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact RICHARD HUNTER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received06/25/1985
Decision Date 09/23/1985
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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