Cleared Traditional

CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION

K852956 · Parker Laboratories, Inc. · Neurology
Aug 1985
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K852956 is an FDA 510(k) clearance for the CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Parker Laboratories, Inc. (Orange, US). The FDA issued a Cleared decision on August 9, 1985, 29 days after receiving the submission on July 11, 1985. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K852956 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1985
Decision Date August 09, 1985
Days to Decision 29 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