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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 K010016
Device Name MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact LISA HOPKINS
Correspondent
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact LISA HOPKINS
Regulation Number868.5090
Classification Product Code
BWC  
Subsequent Product Code
JOH  
Date Received01/02/2001
Decision Date 10/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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