Cleared Traditional

NU-PREP GEL

K933798 · Cadwell Laboratories, Inc. · Neurology
Apr 1994
Decision
261d
Days
Class 1
Risk

About This 510(k) Submission

K933798 is an FDA 510(k) clearance for the NU-PREP GEL, a Esthesiometer (Class I — General Controls, product code GXB), submitted by Cadwell Laboratories, Inc. (Kennewick, US). The FDA issued a Cleared decision on April 22, 1994, 261 days after receiving the submission on August 4, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1500.

Submission Details

510(k) Number K933798 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1993
Decision Date April 22, 1994
Days to Decision 261 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXB — Esthesiometer
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.1500