Cleared Traditional

DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788

K060995 · Duckworth & Kent, Ltd. · Ophthalmic
May 2006
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K060995 is an FDA 510(k) clearance for the DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788, 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 May 22, 2006, 41 days after receiving the submission on April 11, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K060995 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2006
Decision Date May 22, 2006
Days to Decision 41 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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