Cleared Traditional

PRO-PORTION CLEANER/DISINFECTANT

K991509 · Sultan Chemists, Inc. · General Hospital
Jul 1999
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K991509 is an FDA 510(k) clearance for the PRO-PORTION CLEANER/DISINFECTANT, a Disinfectant, Medical Devices (Class I — General Controls, product code LRJ), submitted by Sultan Chemists, Inc. (Englewood, US). The FDA issued a Cleared decision on July 14, 1999, 75 days after receiving the submission on April 30, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6890.

Submission Details

510(k) Number K991509 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 1999
Decision Date July 14, 1999
Days to Decision 75 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