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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Conduction, Anesthetic
510(k) Number K023892
Device Name MILLEX VV, GV, AND HV SYRINGE FILTER UNITS
Applicant
MILLIPORE CORP.
80 ASHBY RD.
BEDFORD,  MA  01730
Applicant Contact THOMAS BORROWS
Correspondent
MILLIPORE CORP.
80 ASHBY RD.
BEDFORD,  MA  01730
Correspondent Contact THOMAS BORROWS
Regulation Number868.5130
Classification Product Code
BSN  
Subsequent Product Code
FPB  
Date Received11/22/2002
Decision Date 01/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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