Cleared Traditional

GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER

K883589 · Gambro, Inc. · Gastroenterology & Urology
Sep 1988
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K883589 is an FDA 510(k) clearance for the GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on September 29, 1988, 38 days after receiving the submission on August 22, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K883589 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1988
Decision Date September 29, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FJI — Dialyzer, Capillary, Hollow Fiber
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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