Cleared Special

FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB

K071387 · Fresenius Medical Care North America · Gastroenterology & Urology
Jun 2007
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K071387 is an FDA 510(k) clearance for the FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB, a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on June 15, 2007, 28 days after receiving the submission on May 18, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K071387 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2007
Decision Date June 15, 2007
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KPO — Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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