Cleared Traditional

MILLIPORE IVEX INT FILTER UNIT

K832952 · Millipore Corp. · General Hospital
Oct 1983
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K832952 is an FDA 510(k) clearance for the MILLIPORE IVEX INT FILTER UNIT, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Millipore Corp. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983, 36 days after receiving the submission on August 29, 1983. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K832952 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1983
Decision Date October 04, 1983
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FPB — Filter, Infusion Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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