Cleared Special

MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME

K032978 · Ciba Vision Corporation · Ophthalmic
Oct 2003
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K032978 is an FDA 510(k) clearance for the MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME, 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 October 20, 2003, 26 days after receiving the submission on September 24, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K032978 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2003
Decision Date October 20, 2003
Days to Decision 26 days
Submission Type Special
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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