OCS-B

Bone Grafting Material, Animal Source

NIBEC COMPANY, LIMITED

The following data is part of a premarket notification filed by Nibec Company, Limited with the FDA for Ocs-b.

Pre-market Notification Details

Device IDK113246
510k NumberK113246
Device Name:OCS-B
ClassificationBone Grafting Material, Animal Source
Applicant NIBEC COMPANY, LIMITED 4568 W. 1ST STREET SUITE 104 Los Angeles,  CA  90004
ContactDaniel Nam
CorrespondentDaniel Nam
NIBEC COMPANY, LIMITED 4568 W. 1ST STREET SUITE 104 Los Angeles,  CA  90004
Product CodeNPM  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-02
Decision Date2013-01-16
Summary:summary

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