Cleared Traditional

K983585 - LOW PH PHENOLIC 256
(FDA 510(k) Clearance)

K983585 · Central Solutions, Inc. · General Hospital

Nov 1998

Decision

24d

Days

Class 1

Risk

K983585 is an FDA 510(k) clearance for the LOW PH PHENOLIC 256, 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 November 6, 1998, 24 days after receiving the submission on October 13, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6890.

Submission Details

510(k) Number	K983585 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 1998
Decision Date	November 06, 1998
Days to Decision	24 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF