Cleared Traditional

ONE UP DISPOSABLE KERATOME HEAD

K981742 · Moria, Inc. · Ophthalmic

Aug 1998

Decision

99d

Days

Class 1

Risk

About This 510(k) Submission

K981742 is an FDA 510(k) clearance for the ONE UP DISPOSABLE KERATOME HEAD, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Moria, Inc. (Antony, FR). The FDA issued a Cleared decision on August 25, 1998, 99 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	K981742 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1998
Decision Date	August 25, 1998
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF