Submission Details
| 510(k) Number | K892349 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 05, 1989 |
| Decision Date | May 26, 1989 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
Cleared
Traditional
K892349 - MAGNILINK SYSTEM 209
(FDA 510(k) Clearance)
May 1989
Decision
51d
Days
Class 1
Risk
K892349 is an FDA 510(k) clearance for the MAGNILINK SYSTEM 209, 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 review panel. Regulated under 21 CFR 886.5820.
Device Classification
| Product Code | HJG — System, Reading, Television, Closed-circuit |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.5820 |
Similar Devices — HJG System, Reading, Television, Closed-circuit
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