NANGEL

Bone Grafting Material, Synthetic

TEKNIMED SA

The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Nangel.

Pre-market Notification Details

Device IDK083005
510k NumberK083005
Device Name:NANGEL
ClassificationBone Grafting Material, Synthetic
Applicant TEKNIMED SA 1001 OAKWOOD BLVD Roundrock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
TEKNIMED SA 1001 OAKWOOD BLVD Roundrock,  TX  78681
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-08
Decision Date2009-03-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.