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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 K942946
Device Name OSTEOGRAF/D-100 HYDROXYLAPATITE
Applicant
Ceramed Corp.
12860 W. Cedar Dr.,
Suite 109
Lakewood,  CO  80228
Applicant Contact BARBARA A WATSON
Correspondent
Ceramed Corp.
12860 W. Cedar Dr.,
Suite 109
Lakewood,  CO  80228
Correspondent Contact BARBARA A WATSON
Regulation Number872.3930
Classification Product Code
LYC  
Date Received06/23/1994
Decision Date 10/05/1994
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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