Cleared Traditional

ERG-JET ELECTRODE

K823767 · Life-Tech Intl., Inc. · Ophthalmic
Jan 1983
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K823767 is an FDA 510(k) clearance for the ERG-JET ELECTRODE, a Device, Measuring, Lens Radius, Ophthalmic (Class I — General Controls, product code HLF), submitted by Life-Tech Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 8, 1983, 25 days after receiving the submission on December 14, 1982. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1430.

Submission Details

510(k) Number K823767 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1982
Decision Date January 08, 1983
Days to Decision 25 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HLF — Device, Measuring, Lens Radius, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1430