Cleared Traditional

ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A

K090002 · Baxter Healthcare Corp · Gastroenterology & Urology
Aug 2009
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K090002 is an FDA 510(k) clearance for the ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A, a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on August 7, 2009, 217 days after receiving the submission on January 2, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K090002 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2009
Decision Date August 07, 2009
Days to Decision 217 days
Submission Type Traditional
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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