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.
| Device ID | K192511 |
| 510k 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 |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | Venner Medical (Singapore) PTE Ltd 35 Joo Koon Circle Singapore, SG 629110 |
| Contact | Adrian P Waterton |
| Correspondent | Christine Brauer Brauer Device Consultants, LLC 7 Trail House Court Rockville, MD 20850 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-12 |
| Decision Date | 2020-07-22 |