Cleared Traditional

GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING

K911459 · Fresenius USA, Inc. · Gastroenterology & Urology
Jul 1991
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K911459 is an FDA 510(k) clearance for the GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING, a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on July 17, 1991, 105 days after receiving the submission on April 3, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K911459 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1991
Decision Date July 17, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

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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