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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 K954631
Device Name OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE
Applicant
Ceramed Corp.
12860 W. Cedar Dr.,
Suite 108
Lakewood,  CO  80228
Applicant Contact MARK BOWERMAN
Correspondent
Ceramed Corp.
12860 W. Cedar Dr.,
Suite 108
Lakewood,  CO  80228
Correspondent Contact MARK BOWERMAN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received10/06/1995
Decision Date 01/02/1996
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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