TRACHEOSTOMY TUBE AND CUFF

Tube, Tracheostomy (w/wo Connector)

CONCORD/PORTEX

The following data is part of a premarket notification filed by Concord/portex with the FDA for Tracheostomy Tube And Cuff.

Pre-market Notification Details

Device IDK912124
510k NumberK912124
Device Name:TRACHEOSTOMY TUBE AND CUFF
ClassificationTube, Tracheostomy (w/wo Connector)
Applicant CONCORD/PORTEX 15 KITT ST. Keene,  NH  03431
ContactRobert Wheeler
CorrespondentRobert Wheeler
CONCORD/PORTEX 15 KITT ST. Keene,  NH  03431
Product CodeBTO  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-13
Decision Date1991-08-16

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