Cleared Traditional

INFUSION CANNULA

K942403 · Microsurgical Technology, Inc. · Ophthalmic
Aug 1994
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K942403 is an FDA 510(k) clearance for the INFUSION CANNULA, a Cannula, Ophthalmic (Class I — General Controls, product code HMX), submitted by Microsurgical Technology, Inc. (Kirkland, US). The FDA issued a Cleared decision on August 17, 1994, 90 days after receiving the submission on May 19, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K942403 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1994
Decision Date August 17, 1994
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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

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