Cleared Traditional

CENTURION SES EPIKERATOME

K031735 · Ciba Vision Corporation · Ophthalmic
Aug 2003
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K031735 is an FDA 510(k) clearance for the CENTURION SES EPIKERATOME, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on August 21, 2003, 78 days after receiving the submission on June 4, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K031735 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2003
Decision Date August 21, 2003
Days to Decision 78 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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