Cleared Traditional

OMS INFUSION CANNULA ASSEMBLE

K813481 · Optical Micro Systems, Inc. · Ophthalmic
Jan 1982
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K813481 is an FDA 510(k) clearance for the OMS INFUSION CANNULA ASSEMBLE, a Cannula, Ophthalmic (Class I — General Controls, product code HMX), submitted by Optical Micro Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982, 52 days after receiving the submission on December 1, 1981. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K813481 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1981
Decision Date January 22, 1982
Days to Decision 52 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HMX — Cannula, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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