K923326 is an FDA 510(k) clearance for the OPHTHALMIC VISCOINJECTOR DRIVE. This device is classified as a Injector, Fluid, Non-electrically Powered (Class II - Special Controls, product code KZE).
Submitted by Synergetics, Inc. (Chesterfield, US). The FDA issued a Cleared decision on September 30, 1992, 85 days after receiving the submission on July 7, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5430.
| 510(k) Number | K923326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1992 |
| Decision Date | September 30, 1992 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZE — Injector, Fluid, Non-electrically Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5430 |