Cleared Traditional

95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS

K974090 · Fresenius Medical Care North America · Gastroenterology & Urology
Aug 1998
Decision
302d
Days
Class 2
Risk

About This 510(k) Submission

K974090 is an FDA 510(k) clearance for the 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS, a Hemodialyzer, Re-use, Low Flux (Class II — Special Controls, product code MSE), submitted by Fresenius Medical Care North America (Walnut Creek, US). The FDA issued a Cleared decision on August 27, 1998, 302 days after receiving the submission on October 29, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K974090 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1997
Decision Date August 27, 1998
Days to Decision 302 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MSE — Hemodialyzer, Re-use, Low Flux
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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