Cleared Abbreviated

MONARCH II IOL DELIVERY SYSTEM

K003768 · Alcon Research, Ltd. · Ophthalmic
Jan 2001
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K003768 is an FDA 510(k) clearance for the MONARCH II IOL DELIVERY SYSTEM, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on January 5, 2001, 30 days after receiving the submission on December 6, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K003768 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2000
Decision Date January 05, 2001
Days to Decision 30 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MSS — Folders And Injectors, Intraocular Lens (iol)
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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