Cleared Traditional

M2 SINGLE USE MICROKERTOME

K022560 · Moria SA · Ophthalmic
Sep 2002
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K022560 is an FDA 510(k) clearance for the M2 SINGLE USE MICROKERTOME, a Keratome, Battery-powered (Class I — General Controls, product code HMY), submitted by Moria SA (Antony, FR). The FDA issued a Cleared decision on September 27, 2002, 56 days after receiving the submission on August 2, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K022560 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2002
Decision Date September 27, 2002
Days to Decision 56 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HMY — Keratome, Battery-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

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