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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 K013916
Device Name MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact HEIDI MASTEN
Correspondent
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact HEIDI MASTEN
Regulation Number868.5090
Classification Product Code
BWC  
Subsequent Product Code
JOH  
Date Received11/27/2001
Decision Date 12/20/2001
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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