Cleared Traditional

CONVERTER SYSTEM

K894248 · Mira, Inc. · Ophthalmic
Feb 1990
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K894248 is an FDA 510(k) clearance for the CONVERTER SYSTEM, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on February 27, 1990, 251 days after receiving the submission on June 21, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K894248 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 1989
Decision Date February 27, 1990
Days to Decision 251 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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