Cleared Traditional

FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM

K921456 · Fresenius USA, Inc. · Gastroenterology & Urology
Apr 1994
Decision
754d
Days
Class 2
Risk

About This 510(k) Submission

K921456 is an FDA 510(k) clearance for the FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM, a System, Dialysate Delivery, Single Patient (Class II — Special Controls, product code FKP), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on April 20, 1994, 754 days after receiving the submission on March 27, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K921456 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1992
Decision Date April 20, 1994
Days to Decision 754 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FKP — System, Dialysate Delivery, Single Patient
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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