The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Nuvent Em Sinus Dilation System.
| Device ID | K152121 |
| 510k Number | K152121 |
| Device Name: | NuVent EM Sinus Dilation System |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 |
| Contact | Gabriela Anchondo |
| Correspondent | Gabriela Anchondo MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-30 |
| Decision Date | 2015-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169770997 | K152121 | 000 |
| 00643169705296 | K152121 | 000 |
| 00643169705302 | K152121 | 000 |
| 00643169770904 | K152121 | 000 |
| 00643169770911 | K152121 | 000 |
| 00643169770928 | K152121 | 000 |
| 00643169770935 | K152121 | 000 |
| 00643169770942 | K152121 | 000 |
| 00643169770959 | K152121 | 000 |
| 00643169770966 | K152121 | 000 |
| 00643169770973 | K152121 | 000 |
| 00643169770980 | K152121 | 000 |
| 00643169705289 | K152121 | 000 |