Cleared Traditional

OMNI PREP GEL

K933797 · Cadwell Laboratories, Inc. · Neurology
May 1994
Decision
286d
Days
Class 2
Risk

About This 510(k) Submission

K933797 is an FDA 510(k) clearance for the OMNI PREP 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 17, 1994, 286 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 K933797 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1993
Decision Date May 17, 1994
Days to Decision 286 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