The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Luma Sinus Illumination System, Model Sis-100a.
| Device ID | K071845 |
| 510k Number | K071845 |
| Device Name: | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A |
| Classification | Cannula, Sinus |
| 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 | KAM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-05 |
| Decision Date | 2007-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031135649 | K071845 | 000 |
| 20705031135632 | K071845 | 000 |