The following data is part of a premarket notification filed by Tracoe Medical Gmbh with the FDA for Tracoe Vario.
| Device ID | K203362 |
| 510k Number | K203362 |
| Device Name: | TRACOE Vario |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | TRACOE Medical GmbH Reichelsheimer Str. 1/3 Nieder-olm, DE 55268 |
| Contact | Katharina Schrick |
| Correspondent | Lu Anne Bauer Capamed Inc. 14 E. Eau Claire Street Unit 447 Rice Lake, WI 54868 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-16 |
| Decision Date | 2021-08-05 |