The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relient Navigation Device.
| Device ID | K060974 |
| 510k Number | K060974 |
| Device Name: | RELIENT NAVIGATION DEVICE |
| Classification | Cannula, Sinus |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Su-mien Chong |
| Correspondent | Su-mien Chong ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | KAM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-10 |
| Decision Date | 2006-05-05 |
| Summary: | summary |