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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K171917
Device Name Frova Intubating Introducer
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 Number868.5730
Classification Product Code
BTR  
Date Received06/27/2017
Decision Date 04/23/2018
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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