Cleared Traditional

K954292 - Q5. 5-5.5NPB-2.5HW
(FDA 510(k) Clearance)

Sep 1995
Decision
13d
Days
Class 1
Risk

K954292 is an FDA 510(k) clearance for the Q5. 5-5.5NPB-2.5HW. 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 September 27, 1995, 13 days after receiving the submission on September 14, 1995.

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

Submission Details

510(k) Number K954292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1995
Decision Date September 27, 1995
Days to Decision 13 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