K874845 is an FDA 510(k) clearance for the MALIS SURGICAL LOUPES. This device is classified as a Loupe, Binocular, Low Power (Class I - General Controls, product code HJH).
Submitted by Valley Forge Scientific Corp. (Valley Forge, US). The FDA issued a Cleared decision on December 23, 1987, 29 days after receiving the submission on November 24, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5120.
| 510(k) Number | K874845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 1987 |
| Decision Date | December 23, 1987 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HJH — Loupe, Binocular, Low Power |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.5120 |