Cleared Traditional

CARRIAZO BARRAQUER II MICROKERATOME

K002191 · Moria, Inc. · Ophthalmic

Oct 2000

Decision

84d

Days

Class 1

Risk

About This 510(k) Submission

K002191 is an FDA 510(k) clearance for the CARRIAZO BARRAQUER II 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 October 12, 2000, 84 days after receiving the submission on July 20, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K002191 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 2000
Decision Date	October 12, 2000
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF