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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K123344
Device Name K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
Applicant
Kawasumi Laboratories, Inc.
7401 104th Ave. Suite 160
Kenosha,  WI  53142
Applicant Contact CHRISTINA HENZA
Correspondent
Kawasumi Laboratories, Inc.
7401 104th Ave. Suite 160
Kenosha,  WI  53142
Correspondent Contact CHRISTINA HENZA
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/31/2012
Decision Date 03/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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