Cleared Traditional

MILLEX VV, GV, AND HV SYRINGE FILTER UNITS

K023892 · Millipore Corp. · Anesthesiology
Jan 2003
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K023892 is an FDA 510(k) clearance for the MILLEX VV, GV, AND HV SYRINGE FILTER UNITS, a Filter, Conduction, Anesthetic (Class II — Special Controls, product code BSN), submitted by Millipore Corp. (Bedford, US). The FDA issued a Cleared decision on January 17, 2003, 56 days after receiving the submission on November 22, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5130.

Submission Details

510(k) Number K023892 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2002
Decision Date January 17, 2003
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSN — Filter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5130

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