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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K040014
Device Name PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
Applicant
Portex , Ltd.
Military Rd.
Hyth, Kent,  GB CT21 6DB
Applicant Contact BARRY SMITH
Correspondent
Portex , Ltd.
Military Rd.
Hyth, Kent,  GB CT21 6DB
Correspondent Contact BARRY SMITH
Regulation Number868.5800
Classification Product Code
JOH  
Date Received12/24/2003
Decision Date 02/13/2004
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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