The following data is part of a premarket notification filed by Oasis Medical, Inc with the FDA for Soft Plug Extended Duration 180 Tapered Canalicular Plug.
| Device ID | K213988 |
| 510k Number | K213988 |
| Device Name: | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug |
| Classification | Plug, Punctum |
| Applicant | Oasis Medical, Inc 514 S Vermont Avenue Glendora, CA 91741 |
| Contact | James Christensen |
| Correspondent | Ting-Hsuan Wu Oasis Medical, Inc 514 S Vermont Avenue Glendora, CA 91741 |
| Product Code | LZU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-06-03 |