The following data is part of a premarket notification filed by Preceptis Medical with the FDA for Hummingbird(tm) Tympanostomy Tube System (tts).
| Device ID | K142282 |
| 510k Number | K142282 |
| Device Name: | HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) |
| 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 | 2014-08-15 |
| Decision Date | 2015-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853386007046 | K142282 | 000 |
| 00853386007053 | K142282 | 000 |
| 00853386007015 | K142282 | 000 |
| 50853386007072 | K142282 | 000 |
| 50853386007065 | K142282 | 000 |