Submission Details
| 510(k) Number | K831285 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 20, 1983 |
| Decision Date | June 03, 1983 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K831285 is an FDA 510(k) clearance for the SURGICAL/LID MARGIN COVER & EYELASH-, a Clamp, Eyelid, Ophthalmic (Class I — General Controls, product code HOD), submitted by Richard R. Anthony, M.D. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1983, 44 days after receiving the submission on April 20, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K831285 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 20, 1983 |
| Decision Date | June 03, 1983 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HOD — Clamp, Eyelid, Ophthalmic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.4350 |