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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, emergency airway
510(k) Number K050166
Device Name PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
Applicant
SMITHS MEDICAL
MILITARY ROAD
HYTHE, KENT,  GB CT 21 5BN
Applicant Contact CHRISTOPHER TURNBULL
Correspondent
SMITHS MEDICAL
MILITARY ROAD
HYTHE, KENT,  GB CT 21 5BN
Correspondent Contact CHRISTOPHER TURNBULL
Regulation Number868.5090
Classification Product Code
BWC  
Date Received01/26/2005
Decision Date 05/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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