Cleared Traditional

CARRIAZO BARRAQUER SINGLE USE MICROKERATOME

K003594 · Moria, Inc. · Ophthalmic

Mar 2001

Decision

108d

Days

Class 1

Risk

About This 510(k) Submission

K003594 is an FDA 510(k) clearance for the CARRIAZO BARRAQUER SINGLE USE MICROKERATOME, a Keratome, Battery-powered (Class I — General Controls, product code HMY), submitted by Moria, Inc. (Antony, FR). The FDA issued a Cleared decision on March 9, 2001, 108 days after receiving the submission on November 21, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K003594 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2000
Decision Date	March 09, 2001
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF