Cleared Traditional

DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786

K081382 · Duckworth & Kent, Ltd. · Ophthalmic
Oct 2008
Decision
160d
Days
Class 1
Risk

About This 510(k) Submission

K081382 is an FDA 510(k) clearance for the DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Duckworth & Kent, Ltd. (Baldock, Hertfordshire, GB). The FDA issued a Cleared decision on October 23, 2008, 160 days after receiving the submission on May 16, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K081382 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2008
Decision Date October 23, 2008
Days to Decision 160 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

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

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