Submission Details
| 510(k) Number | K874251 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 19, 1987 |
| Decision Date | January 11, 1988 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K874251 is an FDA 510(k) clearance for the WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT, a Target, Fusion And Stereoscopic (Class I — General Controls, product code HLP), submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on January 11, 1988, 84 days after receiving the submission on October 19, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1880.
| 510(k) Number | K874251 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 19, 1987 |
| Decision Date | January 11, 1988 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HLP — Target, Fusion And Stereoscopic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.1880 |