Cleared Traditional

AMICON HEMOCONCENTRATOR SET

K901286 · Amicon, Inc. · Gastroenterology & Urology

May 1990

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K901286 is an FDA 510(k) clearance for the AMICON HEMOCONCENTRATOR SET, 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 May 18, 1990, 59 days after receiving the submission on March 20, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K901286 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 1990
Decision Date	May 18, 1990
Days to Decision	59 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