Cleared Traditional

CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)

K901630 · Henley Intl. · Neurology

Jul 1990

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K901630 is an FDA 510(k) clearance for the CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275), a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on July 16, 1990, 98 days after receiving the submission on April 9, 1990. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number	K901630 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 1990
Decision Date	July 16, 1990
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	—