SEALGUARD EVAC ENDOTRACHEAL AND 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 Sealguard Evac Endotracheal And Endotracheal Tubes.

Pre-market Notification Details

Device IDK082520
510k NumberK082520
Device Name:SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
ClassificationTube, Tracheal (w/wo Connector)
Applicant MALLINCKRODT MEDICAL 6135 GUNBARREL AVE. Boulder,  CO  80301
ContactScott D Dickerhoff
CorrespondentScott D Dickerhoff
MALLINCKRODT MEDICAL 6135 GUNBARREL AVE. Boulder,  CO  80301
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-02
Decision Date2008-10-02
Summary:summary

NIH GUDID Devices

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