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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 K192511
Device Name Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
Applicant
Venner Medical (Singapore) Pte, Ltd.
35 Joo Koon Circle
Singapore,  SG 629110
Applicant Contact Adrian P Waterton
Correspondent
Brauer Device Consultants, LLC
7 Trail House Court
Rockville,  MD  20850
Correspondent Contact Christine Brauer
Regulation Number868.5800
Classification Product Code
BTO  
Date Received09/12/2019
Decision Date 07/22/2020
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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