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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
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