K925921 is an FDA 510(k) clearance for the MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE. This device is classified as a Device, Irrigation, Ocular Surgery (Class I - General Controls, product code KYG).
Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on December 6, 1993, 378 days after receiving the submission on November 23, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4360.
| 510(k) Number | K925921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1992 |
| Decision Date | December 06, 1993 |
| Days to Decision | 378 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | KYG — Device, Irrigation, Ocular Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4360 |