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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 K160200
Device Name Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
Applicant
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact Kotei Aoki
Correspondent
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact Kotei Aoki
Regulation Number868.5090
Classification Product Code
BWC  
Subsequent Product Code
JOH  
Date Received01/28/2016
Decision Date 02/17/2017
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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