The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Seeker Balloon Sinuplasty System.
| Device ID | K120280 |
| 510k Number | K120280 |
| Device Name: | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ACCLARENT, INC. 1525-B OBRIEN DR. Menlo Park, CA 94025 |
| Contact | Dan Harfe |
| Correspondent | Dan Harfe ACCLARENT, INC. 1525-B OBRIEN DR. Menlo Park, CA 94025 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-30 |
| Decision Date | 2012-11-05 |
| Summary: | summary |