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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Tracheal Tube
510(k) Number K162729
Device Name Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
Applicant
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47404
Applicant Contact KOTEI AOKI
Correspondent
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47404
Correspondent Contact KOTEI AOKI
Regulation Number868.5790
Classification Product Code
BSR  
Subsequent Product Code
BTR  
Date Received09/29/2016
Decision Date 08/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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