K883575 is an FDA 510(k) clearance for the MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE. This device is classified as a Stand, Instrument, Ophthalmic, Non-powered (Class I - General Controls, product code HMG).
Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on September 12, 1988, 21 days after receiving the submission on August 22, 1988.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1860.
| 510(k) Number | K883575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1988 |
| Decision Date | September 12, 1988 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HMG — Stand, Instrument, Ophthalmic, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1860 |