Cleared Traditional

K083295 - SERIM DISINTEK GTA 2.1%, MODEL: 5164
(FDA 510(k) Clearance)

K083295 · Serim Research Corp. · General Hospital

Mar 2009

Decision

126d

Days

Class 2

Risk

K083295 is an FDA 510(k) clearance for the SERIM DISINTEK GTA 2.1%, MODEL: 5164, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on March 16, 2009, 126 days after receiving the submission on November 10, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K083295 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 2008
Decision Date	March 16, 2009
Days to Decision	126 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF