The following data is part of a premarket notification filed by Anodyne with the FDA for Oasis Lacrimal Intubation Set.
| Device ID | K160710 |
| 510k Number | K160710 |
| Device Name: | Oasis Lacrimal Intubation Set |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | ANODYNE 804 CORPORATE CENTRE DRIVE O' Fallon, MO 63368 |
| Contact | Valerie Anderson |
| Correspondent | Valerie Anderson ANODYNE 804 CORPORATE CENTRE DRIVE O' Fallon, MO 63368 |
| Product Code | OKS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-15 |
| Decision Date | 2016-05-13 |
| Summary: | summary |