The following data is part of a premarket notification filed by Tracoe Medical Gmbh with the FDA for Tracoe Silcosoft Tracheostomy Tube.
| Device ID | K172720 |
| 510k Number | K172720 |
| Device Name: | TRACOE Silcosoft Tracheostomy Tube |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | TRACOE Medical GmbH Reichelsheimer Str. 1/3 Nieder-olm, DE 55268 |
| Contact | Eva Schaeffer |
| Correspondent | Lu Anne Bauer Capamed Inc. 14 E.Eau Claire St. 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 | 2017-09-08 |
| Decision Date | 2018-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035324031849 | K172720 | 000 |
| 04035324032297 | K172720 | 000 |
| 04035324032334 | K172720 | 000 |
| 04035324032228 | K172720 | 000 |