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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 K233341
Device Name Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
Applicant
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Applicant Contact Stephanie Reneau
Correspondent
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact Stephanie Reneau
Regulation Number868.5730
Classification Product Code
BTR  
Date Received09/29/2023
Decision Date 05/20/2024
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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