HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES

Tube, Tracheal (w/wo Connector)

MALLINCKRODT MEDICAL

The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Hi-lo Evac And Evac Ii Endotracheal Tubes.

Pre-market Notification Details

Device IDK965132
510k NumberK965132
Device Name:HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
ClassificationTube, Tracheal (w/wo Connector)
Applicant MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis,  MO  63134
ContactMichael B Schoeck
CorrespondentMichael B Schoeck
MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis,  MO  63134
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-23
Decision Date1997-03-20

NIH GUDID Devices

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