UNCUFFED HI-LO JET TRACHEAL TUBE

Tube, Tracheal (w/wo Connector)

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Uncuffed Hi-lo Jet Tracheal Tube.

Pre-market Notification Details

Device IDK852493
510k NumberK852493
Device Name:UNCUFFED HI-LO JET TRACHEAL TUBE
ClassificationTube, Tracheal (w/wo Connector)
Applicant MALLINCKRODT CRITICAL CARE 73 QUAKER RD. Glens Falls,  NY  12301
ContactPhilip E Wiegert
CorrespondentPhilip E Wiegert
MALLINCKRODT CRITICAL CARE 73 QUAKER RD. Glens Falls,  NY  12301
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-12
Decision Date1985-07-08

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