Cleared Traditional

AMICON MINIFILTER PLUS HEMOFILTER

K895405 · Amicon, Inc. · Gastroenterology & Urology

Jan 1990

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K895405 is an FDA 510(k) clearance for the AMICON MINIFILTER PLUS HEMOFILTER, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Amicon, Inc. (Danvers, US). The FDA issued a Cleared decision on January 11, 1990, 126 days after receiving the submission on September 7, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K895405 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 1989
Decision Date	January 11, 1990
Days to Decision	126 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