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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 K083119
Device Name PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
Applicant
Smiths Medical Asd, Inc.
Boundary Rd.
Hythe, Kent,  GB CT216JN
Applicant Contact JOHN TULLETT
Correspondent
Smiths Medical Asd, Inc.
Boundary Rd.
Hythe, Kent,  GB CT216JN
Correspondent Contact JOHN TULLETT
Regulation Number868.5730
Classification Product Code
BTR  
Date Received10/22/2008
Decision Date 06/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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