Cleared Traditional

HEMOFILTRATION SYSTEM 10

K862716 · Gambro, Inc. · Gastroenterology & Urology
Sep 1986
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K862716 is an FDA 510(k) clearance for the HEMOFILTRATION SYSTEM 10, a System, Dialysate Delivery, Sealed (Class II — Special Controls, product code FII), submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on September 9, 1986, 54 days after receiving the submission on July 17, 1986. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number K862716 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1986
Decision Date September 09, 1986
Days to Decision 54 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FII — System, Dialysate Delivery, Sealed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5860