Cleared Traditional

K952405 - CITRACE HOSPITAL GERMICIDAL DEODORIZER
(FDA 510(k) Clearance)

Aug 1995
Decision
98d
Days
Class 1
Risk

K952405 is an FDA 510(k) clearance for the CITRACE HOSPITAL GERMICIDAL DEODORIZER. This device is classified as a Disinfectant, Medical Devices (Class I - General Controls, product code LRJ).

Submitted by Caltech Industries, Inc. (Midland, US). The FDA issued a Cleared decision on August 28, 1995, 98 days after receiving the submission on May 22, 1995.

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

Submission Details

510(k) Number K952405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1995
Decision Date August 28, 1995
Days to Decision 98 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