K892350 is an FDA 510(k) clearance for the MAGNILINK SYSTEM 402/5. This device is classified as a System, Reading, Television, Closed-circuit (Class I - General Controls, product code HJG).
Submitted by Coburn Optical Ind., Inc. (Tulsa, US). The FDA issued a Cleared decision on May 26, 1989, 51 days after receiving the submission on April 5, 1989.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5820.
| 510(k) Number | K892350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1989 |
| Decision Date | May 26, 1989 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HJG — System, Reading, Television, Closed-circuit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.5820 |