Cleared Traditional

COBURN I/A SYSTEM

K853457 · Coburn Optical Ind., Inc. · Ophthalmic
Oct 1985
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K853457 is an FDA 510(k) clearance for the COBURN I/A SYSTEM, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Coburn Optical Ind., Inc. (Clearwater, US). The FDA issued a Cleared decision on October 15, 1985, 60 days after receiving the submission on August 16, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K853457 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1985
Decision Date October 15, 1985
Days to Decision 60 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150

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