Cleared Traditional

OMS INFUSION-ASPIRATION HANDLE

K813500 · Optical Micro Systems, Inc. · Ophthalmic
Feb 1982
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K813500 is an FDA 510(k) clearance for the OMS INFUSION-ASPIRATION HANDLE, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Optical Micro Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982, 52 days after receiving the submission on December 14, 1981. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K813500 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1981
Decision Date February 04, 1982
Days to Decision 52 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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