Cleared Traditional

FILTRAL TM 20 HEMODIALYZER/FILTER

K893742 · Hospal Medical Corp. · Gastroenterology & Urology

Jul 1989

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K893742 is an FDA 510(k) clearance for the FILTRAL TM 20 HEMODIALYZER/FILTER, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Hospal Medical Corp. (Williamsburg, US). The FDA issued a Cleared decision on July 24, 1989, 68 days after receiving the submission on May 17, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K893742 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 17, 1989
Decision Date	July 24, 1989
Days to Decision	68 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