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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 (W/Wo Connector)
510(k) Number K083031
Device Name PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
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 Number868.5800
Classification Product Code
BTO  
Date Received10/10/2008
Decision Date 08/18/2009
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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