Cleared Traditional

K951317 - PHENO-CEN SPRAY DISINFECTANT DEODORANT
(FDA 510(k) Clearance)

Apr 1995
Decision
33d
Days
Class 1
Risk

K951317 is an FDA 510(k) clearance for the PHENO-CEN SPRAY DISINFECTANT DEODORANT. 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 April 25, 1995, 33 days after receiving the submission on March 23, 1995.

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

Submission Details

510(k) Number K951317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1995
Decision Date April 25, 1995
Days to Decision 33 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