T-TUBE VENT TUBE

Tube, Tympanostomy

TREACE MEDICAL, INC.

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

Pre-market Notification Details

Device IDK823909
510k NumberK823909
Device Name:T-TUBE VENT TUBE
ClassificationTube, Tympanostomy
Applicant TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeETD  
CFR Regulation Number874.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-28
Decision Date1983-03-17

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