Cleared Traditional

MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM

K911998 · Allergan Medical Optics · Ophthalmic
Jul 1991
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K911998 is an FDA 510(k) clearance for the MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Allergan Medical Optics (Anasco, US). The FDA issued a Cleared decision on July 26, 1991, 88 days after receiving the submission on April 29, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K911998 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1991
Decision Date July 26, 1991
Days to Decision 88 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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