Cleared Traditional

AMICON DIAFILTER 30 HEMOCONCENTRATOR

K902837 · Amicon, Inc. · Gastroenterology & Urology

Nov 1990

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K902837 is an FDA 510(k) clearance for the AMICON DIAFILTER 30 HEMOCONCENTRATOR, 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 November 1, 1990, 126 days after receiving the submission on June 28, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K902837 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 1990
Decision Date	November 01, 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