The following data is part of a premarket notification filed by Acclarent, Inc with the FDA for Acclarent Ent Navigation System.
| Device ID | K173628 |
| 510k Number | K173628 |
| Device Name: | Acclarent ENT Navigation System |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Acclarent, Inc 1525-B O’Brien Drive Menlo Park, CA 94025 |
| Contact | James Patrick Garvey |
| Correspondent | James Patrick Garvey Acclarent, Inc 1525-B O’Brien Drive Menlo Park, CA 94025 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-24 |
| Decision Date | 2018-03-10 |
| Summary: | summary |