Cleared Traditional

KLORMAN

K923693 · Matrix Medica, Inc. · General Hospital
Jan 1996
Decision
1279d
Days
Class 1
Risk

About This 510(k) Submission

K923693 is an FDA 510(k) clearance for the KLORMAN, a Disinfectant, Medical Devices (Class I — General Controls, product code LRJ), submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on January 23, 1996, 1279 days after receiving the submission on July 23, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6890.

Submission Details

510(k) Number K923693 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1992
Decision Date January 23, 1996
Days to Decision 1279 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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