Cleared Traditional

TEN-20 CONDUCTIVE PASTE GEL

K933799 · Cadwell Laboratories, Inc. · Neurology
May 1994
Decision
296d
Days
Class 2
Risk

About This 510(k) Submission

K933799 is an FDA 510(k) clearance for the TEN-20 CONDUCTIVE PASTE GEL, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on May 27, 1994, 296 days after receiving the submission on August 4, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K933799 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1993
Decision Date May 27, 1994
Days to Decision 296 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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