Cleared Traditional

O.M.S. GUILLOTINE CUTTER

K844374 · Optical Micro Systems, Inc. · Ophthalmic
Dec 1984
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K844374 is an FDA 510(k) clearance for the O.M.S. GUILLOTINE CUTTER, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Optical Micro Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on December 11, 1984, 28 days after receiving the submission on November 13, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K844374 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1984
Decision Date December 11, 1984
Days to Decision 28 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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