Cleared Traditional

DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM

K024072 · Duckworth & Kent, Ltd. · Ophthalmic
Oct 2003
Decision
300d
Days
Class 1
Risk

About This 510(k) Submission

K024072 is an FDA 510(k) clearance for the DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Duckworth & Kent, Ltd. (Baldock, Hertfordshire, GB). The FDA issued a Cleared decision on October 6, 2003, 300 days after receiving the submission on December 10, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K024072 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2002
Decision Date October 06, 2003
Days to Decision 300 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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