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

Tube, Tracheostomy (w/wo Connector)

Venner Medical (Singapore) PTE Ltd

The following data is part of a premarket notification filed by Venner Medical (singapore) Pte Ltd with the FDA for 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.

Pre-market Notification Details

Device IDK192511
510k NumberK192511
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
ClassificationTube, Tracheostomy (w/wo Connector)
Applicant Venner Medical (Singapore) PTE Ltd 35 Joo Koon Circle Singapore,  SG 629110
ContactAdrian P Waterton
CorrespondentChristine Brauer
Brauer Device Consultants, LLC 7 Trail House Court Rockville,  MD  20850
Product CodeBTO  
CFR Regulation Number868.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-12
Decision Date2020-07-22

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