Cleared Traditional

HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)

K980386 · Gambro Healthcare · Gastroenterology & Urology

Feb 1999

Decision

387d

Days

Class 2

Risk

About This 510(k) Submission

K980386 is an FDA 510(k) clearance for the HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0), a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Gambro Healthcare (Lakewood, US). The FDA issued a Cleared decision on February 24, 1999, 387 days after receiving the submission on February 2, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K980386 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 1998
Decision Date	February 24, 1999
Days to Decision	387 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

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