OSSIX -PLUS

Barrier, Animal Source, Intraoral

COLBAR LIFESCIENCE LTD.

The following data is part of a premarket notification filed by Colbar Lifescience Ltd. with the FDA for Ossix -plus.

Pre-market Notification Details

Device IDK053260
510k NumberK053260
Device Name:OSSIX -PLUS
ClassificationBarrier, Animal Source, Intraoral
Applicant COLBAR LIFESCIENCE LTD. 555 THIRTEENTH STREET, NW Washington,  DC  20004
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
COLBAR LIFESCIENCE LTD. 555 THIRTEENTH STREET, NW Washington,  DC  20004
Product CodeNPL  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-22
Decision Date2006-02-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290015477765 K053260 000
07290015477727 K053260 000
07290015477710 K053260 000

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