Cleared Traditional

CARRIAZO BARRAQUER MICROKERATOME

K981741 · Moria, Inc. · Ophthalmic

Jul 1998

Decision

67d

Days

Class 1

Risk

About This 510(k) Submission

K981741 is an FDA 510(k) clearance for the CARRIAZO BARRAQUER 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 July 24, 1998, 67 days after receiving the submission on May 18, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K981741 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1998
Decision Date	July 24, 1998
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF