The following data is part of a premarket notification filed by Tusker Medical with the FDA for Tula Tube Delivery System.
| Device ID | K171239 |
| 510k Number | K171239 |
| Device Name: | TULA Tube Delivery System |
| Classification | Tube, Tympanostomy |
| Applicant | Tusker Medical 155 Jefferson Drive Suite 200 Menlo Park, CA 94025 |
| Contact | Pavan Sethi |
| Correspondent | Pavan Sethi Tusker Medical 155 Jefferson Drive Suite 200 Menlo Park, CA 94025 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-27 |
| Decision Date | 2017-06-28 |
| Summary: | summary |