The following data is part of a premarket notification filed by Preceptis Medical, Inc with the FDA for Hummingbird Tympanostomy Tube System.
| Device ID | K200952 |
| 510k Number | K200952 |
| Device Name: | Hummingbird Tympanostomy Tube System |
| Classification | Tube, Tympanostomy |
| Applicant | Preceptis Medical, Inc 10900 89th Ave N Suite 4 Maple Grove, MN 55369 |
| Contact | Steve Anderson |
| Correspondent | Steve Anderson Preceptis Medical, Inc 10900 89th Ave N Suite 4 Maple Grove, MN 55369 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-09 |
| Decision Date | 2020-06-05 |