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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 K863176
Device Name ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+
Applicant
Coors Biomedical Co.
12860 W. Cedar Dr.
Suite 210
Lakewood,  CO  80228
Applicant Contact ROBERT C HALE
Correspondent
Coors Biomedical Co.
12860 W. Cedar Dr.
Suite 210
Lakewood,  CO  80228
Correspondent Contact ROBERT C HALE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received08/18/1986
Decision Date 11/26/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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