Cleared Special

BD K-4000 MICROKERATOME SYSTEM

K023092 · Becton, Dickinson & CO · Ophthalmic
Oct 2002
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K023092 is an FDA 510(k) clearance for the BD K-4000 MICROKERATOME SYSTEM, a Keratome, Battery-powered (Class I — General Controls, product code HMY), submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on October 18, 2002, 30 days after receiving the submission on September 18, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K023092 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2002
Decision Date October 18, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HMY — Keratome, Battery-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

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