Cleared Special

FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS

K992275 · Fresenius USA, Inc. · Gastroenterology & Urology

Aug 1999

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K992275 is an FDA 510(k) clearance for the FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on August 4, 1999, 28 days after receiving the submission on July 7, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K992275 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 1999
Decision Date	August 04, 1999
Days to Decision	28 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