Cleared Traditional

HEMO-RO WATER PURIFICATION SYS

K841403 · Millipore Corp. · Gastroenterology & Urology
Jul 1984
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K841403 is an FDA 510(k) clearance for the HEMO-RO WATER PURIFICATION SYS, a Subsystem, Water Purification (Class II — Special Controls, product code FIP), submitted by Millipore Corp. (Walker, US). The FDA issued a Cleared decision on July 6, 1984, 94 days after receiving the submission on April 3, 1984. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.

Submission Details

510(k) Number K841403 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1984
Decision Date July 06, 1984
Days to Decision 94 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FIP — Subsystem, Water Purification
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5665

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