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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, animal source
510(k) Number K113246
FOIA Releasable 510(k) K113246
Device Name OCS-B
Applicant
NIBEC COMPANY, LIMITED
4568 W. 1ST STREET
SUITE 104
LOS ANGELES,  CA  90004
Applicant Contact DANIEL NAM
Correspondent
NIBEC COMPANY, LIMITED
4568 W. 1ST STREET
SUITE 104
LOS ANGELES,  CA  90004
Correspondent Contact DANIEL NAM
Regulation Number872.3930
Classification Product Code
NPM  
Date Received11/02/2011
Decision Date 01/16/2013
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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