The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Tytan Reuter Bobbin Vent Tube.
| Device ID | K822376 |
| 510k Number | K822376 |
| Device Name: | TYTAN REUTER BOBBIN VENT TUBE |
| Classification | Tube, Tympanostomy |
| Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-06 |
| Decision Date | 1982-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20681490032029 | K822376 | 000 |
| 20681490032005 | K822376 | 000 |
| 20681490031992 | K822376 | 000 |
| 20681490031961 | K822376 | 000 |
| 20763000039435 | K822376 | 000 |
| 20763000039428 | K822376 | 000 |