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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 K090352
Device Name TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
Applicant
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80516
Applicant Contact TED KUHN
Correspondent
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80516
Correspondent Contact TED KUHN
Regulation Number868.5730
Classification Product Code
BTR  
Date Received02/11/2009
Decision Date 04/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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