K925828 is an FDA 510(k) clearance for the MODIFIED SITE TXR SYSTEMS. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on February 16, 1994, 457 days after receiving the submission on November 16, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K925828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 1992 |
| Decision Date | February 16, 1994 |
| Days to Decision | 457 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |