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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 K891173
Device Name OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60
Applicant
Ceramed Corp.
12860 W. Cedar Dr.,
Suite 108
Lakewood,  CO  80228
Applicant Contact KERRY L GRAF
Correspondent
Ceramed Corp.
12860 W. Cedar Dr.,
Suite 108
Lakewood,  CO  80228
Correspondent Contact KERRY L GRAF
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/06/1989
Decision Date 09/01/1989
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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