K950599 is an FDA 510(k) clearance for the STORS SCLERAL SPONGE II (LINCOFF DESIGN). This device is classified as a Implant, Orbital, Extra-ocular (Class II - Special Controls, product code HQX).
Submitted by Storz Ophthalmics, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 2, 1995, 21 days after receiving the submission on February 9, 1995.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3340.
| 510(k) Number | K950599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1995 |
| Decision Date | March 02, 1995 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQX — Implant, Orbital, Extra-ocular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3340 |