K950241 is an FDA 510(k) clearance for the OPHTHALMIC SPONGES. This device is classified as a Sponge, Ophthalmic (Class II - Special Controls, product code HOZ).
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on February 27, 1995, 38 days after receiving the submission on January 20, 1995.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4790.
| 510(k) Number | K950241 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 1995 |
| Decision Date | February 27, 1995 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HOZ - Sponge, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4790 |