Cleared Traditional

CONTROL III ELITE

K992661 · Maril Products, Inc. · General Hospital

Sep 1999

Decision

36d

Days

Class 1

Risk

About This 510(k) Submission

K992661 is an FDA 510(k) clearance for the CONTROL III ELITE, a Disinfectant, Medical Devices (Class I — General Controls, product code LRJ), submitted by Maril Products, Inc. (Tustin, US). The FDA issued a Cleared decision on September 14, 1999, 36 days after receiving the submission on August 9, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6890.

Submission Details

510(k) Number	K992661 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 1999
Decision Date	September 14, 1999
Days to Decision	36 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement