The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Relieva Stratus Pro Microflow Spacer (frontal).
| Device ID | K110687 |
| 510k Number | K110687 |
| Device Name: | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) |
| Classification | Cannula, Sinus |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Dean Knight |
| Correspondent | Dean Knight 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 | 2011-03-11 |
| Decision Date | 2011-10-07 |
| Summary: | summary |