SERIM DISINTEK GTA 2.1%, MODEL: 5164— 510(k) K083295

Name: FDA 510(k) clearance K083295
Creator: U.S. Food and Drug Administration
Published: 2009-03-16

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K083295 for SERIM DISINTEK GTA 2.1%, MODEL: 5164, Substantially Equivalent on 2009-03-16. Applicant: Serim Research Corp.. Device class: 2.

Clearance details

Applicant: Serim Research Corp.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2008-11-10
Decision date: 2009-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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