Cleared Traditional

BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME

K022637 · Becton, Dickinson & CO · Ophthalmic
Oct 2002
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K022637 is an FDA 510(k) clearance for the BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME, 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 16, 2002, 69 days after receiving the submission on August 8, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K022637 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2002
Decision Date October 16, 2002
Days to Decision 69 days
Submission Type Traditional
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