The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Ethmoid Sinus Spacer.
| Device ID | K062458 |
| 510k Number | K062458 |
| Device Name: | ETHMOID SINUS SPACER |
| Classification | Cannula, Sinus |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Debbie Cogan |
| Correspondent | Debbie Cogan 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 | 2006-08-23 |
| Decision Date | 2006-09-15 |
| Summary: | summary |