Cleared Traditional

MAGNILINK SYSTEM 602

K892351 · Coburn Optical Ind., Inc. · Ophthalmic
May 1989
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K892351 is an FDA 510(k) clearance for the MAGNILINK SYSTEM 602, 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.

Submission Details

510(k) Number K892351 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 —

Device Classification

Product Code HJG — System, Reading, Television, Closed-circuit
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.5820

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