TRACH T WITH ONE-WAY VALVES

Connector, Airway (extension)

AIRLIFE, INC.

The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Trach T With One-way Valves.

Pre-market Notification Details

Device IDK790888
510k NumberK790888
Device Name:TRACH T WITH ONE-WAY VALVES
ClassificationConnector, Airway (extension)
Applicant AIRLIFE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBZA  
CFR Regulation Number868.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-05-07
Decision Date1979-06-27

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