Cleared Traditional

FILTRAL TM 8 HEMODIALYZER

K884326 · Hospal Medical Corp. · Gastroenterology & Urology

Dec 1988

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K884326 is an FDA 510(k) clearance for the FILTRAL TM 8 HEMODIALYZER, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Hospal Medical Corp. (Edison, US). The FDA issued a Cleared decision on December 5, 1988, 52 days after receiving the submission on October 14, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K884326 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 14, 1988
Decision Date	December 05, 1988
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—

Device Classification

Product Code	KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5860