The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Ophthalmic Sponges.
| Device ID | K950241 |
| 510k Number | K950241 |
| Device Name: | OPHTHALMIC SPONGES |
| Classification | Sponge, Ophthalmic |
| Applicant | OASIS MEDICAL, INC. 514 SOUTH VERMONT AVE. P.O. BOX 1137 Glendora, CA 91741 |
| Contact | Norman Delgado |
| Correspondent | Norman Delgado OASIS MEDICAL, INC. 514 SOUTH VERMONT AVE. P.O. BOX 1137 Glendora, CA 91741 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-20 |
| Decision Date | 1995-02-27 |