Cleared Traditional

MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)

K963717 · Millipore Corp. · Anesthesiology
Jun 1997
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K963717 is an FDA 510(k) clearance for the MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS), a Filter, Conduction, Anesthetic (Class II — Special Controls, product code BSN), submitted by Millipore Corp. (Bedford, US). The FDA issued a Cleared decision on June 10, 1997, 267 days after receiving the submission on September 16, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5130.

Submission Details

510(k) Number K963717 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1996
Decision Date June 10, 1997
Days to Decision 267 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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