The following data is part of a premarket notification filed by Trudell Medical International with the FDA for Corrugated Tube With Mouthpiece Accessory.
| Device ID | K203400 |
| 510k Number | K203400 |
| Device Name: | Corrugated Tube With Mouthpiece Accessory |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Trudell Medical International 725 Baransway Drive London, CA N5v 5g4 |
| Contact | Marianne Tanton |
| Correspondent | Marianne Tanton Trudell Medical International 725 Baransway Drive London, CA N5v 5g4 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-19 |
| Decision Date | 2021-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10762860055572 | K203400 | 000 |