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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 K981214
Device Name OSTEOGRAF/N-700
Applicant
CERAMED DENTAL, LLC.
12860 WEST CEDAR DR.,
SUITE 110
LAKEWOOD,  CO  80228
Applicant Contact MARK BOWERMAN
Correspondent
CERAMED DENTAL, LLC.
12860 WEST CEDAR DR.,
SUITE 110
LAKEWOOD,  CO  80228
Correspondent Contact MARK BOWERMAN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received04/02/1998
Decision Date 06/26/1998
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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