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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 K142040
Device Name OCS-B COLLAGEN
Applicant
Nibec Co., Ltd.
904 E. Windsor Rd. #102
Glendale,  CA  91203
Applicant Contact DANIEL NAM
Correspondent
Nibec Co., Ltd.
904 E. Windsor Rd. #102
Glendale,  CA  91203
Correspondent Contact DANIEL NAM
Regulation Number872.3930
Classification Product Code
NPM  
Date Received07/28/2014
Decision Date 07/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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