Cleared Traditional

THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE

K930842 · Grieshaber & Co. · Ophthalmic
May 1994
Decision
440d
Days
Class 2
Risk

About This 510(k) Submission

K930842 is an FDA 510(k) clearance for the THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Grieshaber & Co. (Kennesaw, US). The FDA issued a Cleared decision on May 3, 1994, 440 days after receiving the submission on February 17, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K930842 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 1993
Decision Date May 03, 1994
Days to Decision 440 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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