The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Silicone Punctal Plug.
| Device ID | K945906 |
| 510k Number | K945906 |
| Device Name: | SILICONE PUNCTAL PLUG |
| Classification | Plug, Punctum |
| Applicant | OASIS MEDICAL, INC. 514 SOUTH VERMONT AVE. Glendora, CA 91741 |
| Contact | Norman Delgado |
| Correspondent | Norman Delgado OASIS MEDICAL, INC. 514 SOUTH VERMONT AVE. 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 | 1994-12-02 |
| Decision Date | 1995-01-03 |