Cleared Traditional

AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE

K941603 · Allergan Medical Optics · Ophthalmic
Jul 1994
Decision
96d
Days
Class 1
Risk

About This 510(k) Submission

K941603 is an FDA 510(k) clearance for the AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Allergan Medical Optics (Irvine, US). The FDA issued a Cleared decision on July 6, 1994, 96 days after receiving the submission on April 1, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K941603 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1994
Decision Date July 06, 1994
Days to Decision 96 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code KYB — Lens, Guide, Intraocular
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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