T-TUBE INSERTER

Source, Carrier, Fiberoptic Light

TREACE MEDICAL, INC.

The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for T-tube Inserter.

Pre-market Notification Details

Device IDK831590
510k NumberK831590
Device Name:T-TUBE INSERTER
ClassificationSource, Carrier, Fiberoptic Light
Applicant TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEQH  
CFR Regulation Number874.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-17
Decision Date1983-06-15

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