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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 K133004
Device Name VENTED MILLEX -GV, CATHIVEX -GV
Applicant
MERCK MILLIPORE LTD.
28820 SINGLE OAK DRIVE
TEMECULA,  CA  92590
Applicant Contact CINDY PENNY
Correspondent
MERCK MILLIPORE LTD.
28820 SINGLE OAK DRIVE
TEMECULA,  CA  92590
Correspondent Contact CINDY PENNY
Regulation Number868.5130
Classification Product Code
BSN  
Date Received09/25/2013
Decision Date 03/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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