Cleared Traditional

MULTIFLOW(TM) 60 KIT

K884365 · Hospal Medical Corp. · Gastroenterology & Urology
Dec 1988
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K884365 is an FDA 510(k) clearance for the MULTIFLOW(TM) 60 KIT, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Hospal Medical Corp. (Edison, US). The FDA issued a Cleared decision on December 8, 1988, 51 days after receiving the submission on October 18, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number K884365 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 1988
Decision Date December 08, 1988
Days to Decision 51 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

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