Cleared Special

MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R

K013988 · Millipore Corp. · Anesthesiology
Apr 2002
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K013988 is an FDA 510(k) clearance for the MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R, a Filter, Conduction, Anesthetic (Class II — Special Controls, product code BSN), submitted by Millipore Corp. (Bedford, US). The FDA issued a Cleared decision on April 4, 2002, 121 days after receiving the submission on December 4, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5130.

Submission Details

510(k) Number K013988 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2001
Decision Date April 04, 2002
Days to Decision 121 days
Submission Type Special
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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