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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 K151381
Device Name Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
Applicant
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80301
Applicant Contact Danielle Mueller
Correspondent
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact Danielle Mueller
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/22/2015
Decision Date 12/11/2015
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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