Cleared Traditional

ELECTROCONDUCTIVE MEDIA

K904377 · Henley Intl. · Neurology
Nov 1991
Decision
417d
Days
Class 2
Risk

About This 510(k) Submission

K904377 is an FDA 510(k) clearance for the ELECTROCONDUCTIVE MEDIA, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on November 15, 1991, 417 days after receiving the submission on September 24, 1990. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K904377 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1990
Decision Date November 15, 1991
Days to Decision 417 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GYB — Media, Electroconductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1275