K840101 is an FDA 510(k) clearance for the EYE SURGERY INSTRUMENT. This device is classified as a Clamp, Muscle, Ophthalmic (Class I - General Controls, product code HOB).
Submitted by Truline Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984, 66 days after receiving the submission on January 10, 1984.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K840101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1984 |
| Decision Date | March 16, 1984 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HOB — Clamp, Muscle, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |