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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 K161813
Device Name Frova Intubating Introducer
Applicant
William Cook Europe Aps
Sandet 6
Bjaeverskov,  DK 4632
Applicant Contact Henriette Stordal Christiansen
Correspondent
William Cook Europe Aps
Sandet 6
Bjaeverskov,  DK 4632
Correspondent Contact Henriette Stordal Christiansen
Regulation Number868.5730
Classification Product Code
BTR  
Date Received07/01/2016
Decision Date 05/19/2017
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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