Cleared Traditional

K952336 - DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH
(FDA 510(k) Clearance)

Aug 1995
Decision
102d
Days
Class 1
Risk

K952336 is an FDA 510(k) clearance for the DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH. 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, 102 days after receiving the submission on May 18, 1995.

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

Submission Details

510(k) Number K952336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1995
Decision Date August 28, 1995
Days to Decision 102 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