Cleared Special

K093902 - MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
(FDA 510(k) Clearance)

K093902 · Fresenius Medical Care North America · Gastroenterology & Urology

May 2010

Decision

156d

Days

Class 2

Risk

K093902 is an FDA 510(k) clearance for the MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius Medical Care North America (Waltham,, US). The FDA issued a Cleared decision on May 27, 2010, 156 days after receiving the submission on December 22, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K093902 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2009
Decision Date	May 27, 2010
Days to Decision	156 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5860