The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Scout Sinus Dilation System.
| Device ID | K140160 |
| 510k Number | K140160 |
| Device Name: | RELIEVA SCOUT SINUS DILATION SYSTEM |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | James P Garvey, Ii |
| Correspondent | James P Garvey, Ii ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-02-20 |
| Summary: | summary |