Cleared Traditional

CAPSULE TENSION RING INSERTER, MODEL 7-810

K042478 · Duckworth & Kent, Ltd. · Ophthalmic
Dec 2004
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K042478 is an FDA 510(k) clearance for the CAPSULE TENSION RING INSERTER, MODEL 7-810, a Injector, Capsular Tension Ring (Class I — General Controls, product code NCE), submitted by Duckworth & Kent, Ltd. (Baldock, Hertfordshire, GB). The FDA issued a Cleared decision on December 28, 2004, 106 days after receiving the submission on September 13, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K042478 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2004
Decision Date December 28, 2004
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code NCE — Injector, Capsular Tension Ring
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300