Cleared Traditional

K944179 - CONTROL III DISINFECTANT GERMICIDE
(FDA 510(k) Clearance)

Mar 1995
Decision
208d
Days
Class 1
Risk

K944179 is an FDA 510(k) clearance for the CONTROL III DISINFECTANT GERMICIDE. This device is classified as a Disinfectant, Medical Devices (Class I - General Controls, product code LRJ).

Submitted by Maril Products, Inc. (Tustin, US). The FDA issued a Cleared decision on March 22, 1995, 208 days after receiving the submission on August 26, 1994.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6890.

Submission Details

510(k) Number K944179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1994
Decision Date March 22, 1995
Days to Decision 208 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LRJ — Disinfectant, Medical Devices
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.6890