Cleared Traditional

K032836 - M3 MICROKERATOME
(FDA 510(k) Clearance)

K032836 · Moria SA · Ophthalmic

Jun 2004

Decision

281d

Days

Class 1

Risk

K032836 is an FDA 510(k) clearance for the M3 MICROKERATOME, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Moria SA (Antony, FR). The FDA issued a Cleared decision on June 18, 2004, 281 days after receiving the submission on September 11, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K032836 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2003
Decision Date	June 18, 2004
Days to Decision	281 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF