The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Soft Plug Extended Duration 180 Canalicular Plug.
| Device ID | K162361 |
| 510k Number | K162361 |
| Device Name: | Soft Plug Extended Duration 180 Canalicular Plug |
| Classification | Plug, Punctum |
| Applicant | OASIS MEDICAL, INC. 514 S. VERMONT AVENUE Glendora, CA 91741 |
| Contact | James Christensen |
| Correspondent | James Christensen 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 | 2016-08-23 |
| Decision Date | 2017-04-17 |
| Summary: | summary |