The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Em Sinus Dilation System.
| Device ID | K132297 |
| 510k Number | K132297 |
| Device Name: | EM SINUS DILATION SYSTEM |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Rozanne Paciej |
| Correspondent | Rozanne Paciej MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. 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 | 2013-07-24 |
| Decision Date | 2013-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169434837 | K132297 | 000 |
| 00643169420410 | K132297 | 000 |
| 00643169420427 | K132297 | 000 |
| 00643169420434 | K132297 | 000 |
| 00643169420441 | K132297 | 000 |
| 00643169420458 | K132297 | 000 |
| 00643169420465 | K132297 | 000 |
| 00643169420472 | K132297 | 000 |
| 00643169420489 | K132297 | 000 |
| 00643169420403 | K132297 | 000 |