Cleared Traditional

TRAV-LER KIT

K943942 · John O. Butler Co. · Dental
Mar 1995
Decision
208d
Days
Class 1
Risk

About This 510(k) Submission

K943942 is an FDA 510(k) clearance for the TRAV-LER KIT, a Toothbrush, Powered (Class I — General Controls, product code JEQ), submitted by John O. Butler Co. (Chicago, US). The FDA issued a Cleared decision on March 8, 1995, 208 days after receiving the submission on August 12, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.6865.

Submission Details

510(k) Number K943942 FDA.gov
FDA Decision Cleared SESK
Date Received August 12, 1994
Decision Date March 08, 1995
Days to Decision 208 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEQ — Toothbrush, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6865

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