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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 K942212
Device Name OSTEOGRAF/LD-300 HYDROXYLAPATITE
Applicant
Ceramed Corp.
12860 W. Cedar Dr.,
Suite 108
Lakewood,  CO  80228
Applicant Contact BARBARA WATSON
Correspondent
Ceramed Corp.
12860 W. Cedar Dr.,
Suite 108
Lakewood,  CO  80228
Correspondent Contact BARBARA WATSON
Regulation Number872.3930
Classification Product Code
LYC  
Date Received05/06/1994
Decision Date 08/23/1994
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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