Cleared Traditional

CREAM, SIGNA

K782055 · Parker Laboratories, Inc. · Neurology
Mar 1979
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K782055 is an FDA 510(k) clearance for the CREAM, SIGNA, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 21, 1979, 100 days after receiving the submission on December 11, 1978. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K782055 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1978
Decision Date March 21, 1979
Days to Decision 100 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