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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 K962786
Device Name OSTEOGRAF STAINLESS STEEL SYRING
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 Received07/17/1996
Decision Date 08/01/1996
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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