K990671 is an FDA 510(k) clearance for the DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE. This device is classified as a Sponge, Ophthalmic (Class II - Special Controls, product code HOZ).
Submitted by Hurricane Medical (Bradenton, US). The FDA issued a Cleared decision on May 10, 1999, 69 days after receiving the submission on March 2, 1999.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4790.
| 510(k) Number | K990671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1999 |
| Decision Date | May 10, 1999 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HOZ — Sponge, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4790 |