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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 K100950
Device Name VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
Applicant
Venner Medical (Singapore) Pte, Ltd.
2626 Valley View Ln.,
Suite 4
Dallas,  TX  75234
Applicant Contact JUDY BURTON
Correspondent
Venner Medical (Singapore) Pte, Ltd.
2626 Valley View Ln.,
Suite 4
Dallas,  TX  75234
Correspondent Contact JUDY BURTON
Regulation Number868.5800
Classification Product Code
BTO  
Date Received04/06/2010
Decision Date 07/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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