Cleared Traditional

DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797

K053176 · Duckworth & Kent, Ltd. · Ophthalmic
Jan 2006
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K053176 is an FDA 510(k) clearance for the DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797, 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 January 30, 2006, 77 days after receiving the submission on November 14, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K053176 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2005
Decision Date January 30, 2006
Days to Decision 77 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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