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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 K013241
Device Name ARNDT 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  
Date Received09/28/2001
Decision Date 02/21/2002
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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