Cleared Traditional

K951020 - TRI-CEN GERMICIDAL DETERGENT
(FDA 510(k) Clearance)

Aug 1995
Decision
174d
Days
Class 1
Risk

K951020 is an FDA 510(k) clearance for the TRI-CEN GERMICIDAL DETERGENT. This device is classified as a Disinfectant, Medical Devices (Class I - General Controls, product code LRJ).

Submitted by Central Solutions, Inc. (Kansas City, US). The FDA issued a Cleared decision on August 28, 1995, 174 days after receiving the submission on March 7, 1995.

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

Submission Details

510(k) Number K951020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1995
Decision Date August 28, 1995
Days to Decision 174 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