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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 K862324
Device Name OSTEOGRAF/AR AND OSTEOGRAF/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 Received06/19/1986
Decision Date 08/15/1986
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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