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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 K902295
Device Name OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH
Applicant
CERAMED CORP.
12860 WEST CEDAR DRIVE,
SUITE 108
LAKEWOOD,  CO  80228
Applicant Contact BARBARA WATSON
Correspondent
CERAMED CORP.
12860 WEST CEDAR DRIVE,
SUITE 108
LAKEWOOD,  CO  80228
Correspondent Contact BARBARA WATSON
Regulation Number872.3930
Classification Product Code
LYC  
Date Received05/22/1990
Decision Date 12/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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