K946016 is an FDA 510(k) clearance for the IVALON OPHTHALMIC SPONGE. This device is classified as a Sponge, Ophthalmic (Class II - Special Controls, product code HOZ).
Submitted by Ivalon (San Diego, US). The FDA issued a Cleared decision on March 22, 1995, 103 days after receiving the submission on December 9, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4790.
| 510(k) Number | K946016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1994 |
| Decision Date | March 22, 1995 |
| Days to Decision | 103 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 |