The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Xpress Multi-sinus Dilation System.
| Device ID | K152434 |
| 510k Number | K152434 |
| Device Name: | XprESS Multi-Sinus Dilation System |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-27 |
| Decision Date | 2015-11-20 |
| Summary: | summary |