PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

Needle, Emergency Airway

SMITHS MEDICAL

The following data is part of a premarket notification filed by Smiths Medical with the FDA for Portex Emergency Cricothyroidotomy Kit.

Pre-market Notification Details

Device IDK050166
510k NumberK050166
Device Name:PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
ClassificationNeedle, Emergency Airway
Applicant SMITHS MEDICAL MILITARY ROAD Hythe, Kent,  GB Ct 21 5bn
ContactChristopher Turnbull
CorrespondentChristopher Turnbull
SMITHS MEDICAL MILITARY ROAD Hythe, Kent,  GB Ct 21 5bn
Product CodeBWC  
CFR Regulation Number868.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-26
Decision Date2005-05-26
Summary:summary

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