The following data is part of a premarket notification filed by Sinusys Corporation with the FDA for Vent-os Sinus Dilation Family.
| Device ID | K160770 |
| 510k Number | K160770 |
| Device Name: | Vent-Os Sinus Dilation Family |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | SINUSYS CORPORATION 2468 EMBARCADERO WAY Palo Alto, CA 94303 |
| Contact | Lloyd H. Griese |
| Correspondent | Lloyd H. Griese SINUSYS CORPORATION 2468 EMBARCADERO WAY Palo Alto, CA 94303 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-21 |
| Decision Date | 2016-06-29 |
| Summary: | summary |