Cleared Traditional

DISPOSABLE M2-PE MICROKERATOME BLADES

K030401 · Oasis Medical, Inc. · Ophthalmic
Jun 2003
Decision
133d
Days
Class 1
Risk

About This 510(k) Submission

K030401 is an FDA 510(k) clearance for the DISPOSABLE M2-PE MICROKERATOME BLADES, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on June 19, 2003, 133 days after receiving the submission on February 6, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K030401 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2003
Decision Date June 19, 2003
Days to Decision 133 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HNO — Keratome, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

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