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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/bronchial, differential ventilation (w/wo connector)
510(k) Number K180253
Device Name Sheridan Endobronchial Tubes
Applicant
Teleflex Medical
3015 Carrington Mills Blvd
Morrisville,  NC  27560
Applicant Contact Lori Pfohl
Correspondent
Teleflex Medical
3015 Carrington Mills Blvd
Morrisville,  NC  27560
Correspondent Contact Lori Pfohl
Regulation Number868.5740
Classification Product Code
CBI  
Date Received01/30/2018
Decision Date 11/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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