Cleared Traditional

DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2

K072985 · Duckworth & Kent, Ltd. · Ophthalmic
Jun 2008
Decision
241d
Days
Class 1
Risk

About This 510(k) Submission

K072985 is an FDA 510(k) clearance for the DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2, 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 June 20, 2008, 241 days after receiving the submission on October 23, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K072985 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2007
Decision Date June 20, 2008
Days to Decision 241 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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