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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 K960353
Device Name OSTEOGRAF/LD-300 HYDROXYLAPATITE
Applicant
CERAMED CORP.
12860 WEST CEDAR DR., STE. 110
LAKEWOOD,  CO  80228
Applicant Contact BARBARA A WATSON
Correspondent
CERAMED CORP.
12860 WEST CEDAR DR., STE. 110
LAKEWOOD,  CO  80228
Correspondent Contact BARBARA A WATSON
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/25/1996
Decision Date 04/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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