The following data is part of a premarket notification filed by Preceptis Medical with the FDA for Hummingbird Tympanostomy Tube.
| Device ID | K151830 |
| 510k Number | K151830 |
| Device Name: | Hummingbird Tympanostomy Tube |
| Classification | Tube, Tympanostomy |
| Applicant | PRECEPTIS MEDICAL 505 HIGHWAY 169 NORTH, #365 Plymouth, MN 55441 |
| Contact | Keith Leland |
| Correspondent | Keith Leland PRECEPTIS MEDICAL 505 HIGHWAY 169 NORTH, #365 Plymouth, MN 55441 |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2015-09-21 |
| Summary: | summary |