The following data is part of a premarket notification filed by Venner Medical (singapore) Pte Ltd with the FDA for Venner Pneux P.y. (tm) Tracheostomy Tube.
| Device ID | K100950 |
| 510k Number | K100950 |
| Device Name: | VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | VENNER MEDICAL (SINGAPORE) PTE LTD 2626 VALLEY VIEW LANE, SUITE 4 Dallas, TX 75234 |
| Contact | Judy Burton |
| Correspondent | Judy Burton VENNER MEDICAL (SINGAPORE) PTE LTD 2626 VALLEY VIEW LANE, SUITE 4 Dallas, TX 75234 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-06 |
| Decision Date | 2010-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28885009190848 | K100950 | 000 |
| 28885009190831 | K100950 | 000 |
| 28885009190824 | K100950 | 000 |
| 08885009190813 | K100950 | 000 |
| 08885009190806 | K100950 | 000 |
| 08885009190790 | K100950 | 000 |