The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Xpress Multi-sinus Dilation Tool.
| Device ID | K132440 |
| 510k Number | K132440 |
| Device Name: | XPRESS MULTI-SINUS DILATION TOOL |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | Entellus Medical, Inc. 3600 HOLLY LANE NORTH SUITE 40 Plymouth, MN 55447 |
| Contact | Karen E Peterson |
| Correspondent | Karen E Peterson Entellus Medical, Inc. 3600 HOLLY LANE NORTH SUITE 40 Plymouth, MN 55447 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-06 |
| Decision Date | 2013-10-04 |
| Summary: | summary |