Cleared Special

ULTRACONCENTRATOR SYSTEM

K011148 · Interpore Cross Intl. · Gastroenterology & Urology
Jun 2001
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K011148 is an FDA 510(k) clearance for the ULTRACONCENTRATOR SYSTEM, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on June 13, 2001, 58 days after receiving the submission on April 16, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K011148 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2001
Decision Date June 13, 2001
Days to Decision 58 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FJI — Dialyzer, Capillary, Hollow Fiber
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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