Submission Details
| 510(k) Number | K841759 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 1984 |
| Decision Date | June 01, 1984 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K841759 is an FDA 510(k) clearance for the OPHTHALMIC TABLE, a Stand, Instrument, Ophthalmic, Non-powered (Class I — General Controls, product code HMG), submitted by Woodlyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1984, 35 days after receiving the submission on April 27, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1860.
| 510(k) Number | K841759 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 1984 |
| Decision Date | June 01, 1984 |
| Days to Decision | 35 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 |