The following data is part of a premarket notification filed by Sinusys Corporation with the FDA for Vent-os Sinus Dilation System.
| Device ID | K133016 |
| 510k Number | K133016 |
| Device Name: | VENT-OS SINUS DILATION SYSTEM |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | SINUSYS CORPORATION 8 SNOWBERRY COURT Orinda, CA 94563 |
| Contact | Michaele A Daniel |
| Correspondent | Michaele A Daniel SINUSYS CORPORATION 8 SNOWBERRY COURT Orinda, CA 94563 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-25 |
| Decision Date | 2013-12-09 |
| Summary: | summary |