The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Spin Sinus Dilation System.
| Device ID | K111875 |
| 510k Number | K111875 |
| Device Name: | RELIEVA SPIN SINUS DILATION SYSTEM |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Keri Yen |
| Correspondent | Keri Yen ACCLARENT, INC. 1525-B O'BRIEN 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 | 2011-07-01 |
| Decision Date | 2011-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031230580 | K111875 | 000 |
| 20705031230573 | K111875 | 000 |
| 20705031227573 | K111875 | 000 |
| 20705031206318 | K111875 | 000 |
| 20705031206301 | K111875 | 000 |
| 20705031206035 | K111875 | 000 |
| 20705031206028 | K111875 | 000 |
| 20705031200583 | K111875 | 000 |
| 20705031200569 | K111875 | 000 |
| 20705031230597 | K111875 | 000 |
| 20705031200538 | K111875 | 000 |
| 20705031230566 | K111875 | 000 |
| 20705031227580 | K111875 | 000 |
| 20705031206370 | K111875 | 000 |
| 20705031206325 | K111875 | 000 |
| 20705031206042 | K111875 | 000 |
| 20705031206011 | K111875 | 000 |
| 20705031200576 | K111875 | 000 |
| 20705031200545 | K111875 | 000 |
| 20705031200552 | K111875 | 000 |