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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 K100720
Device Name K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING
Applicant
Kawasumi Laboratories, Inc.
1601 K St. NW
Washington,  DC  20006
Applicant Contact SUZAN ONEL
Correspondent
Kawasumi Laboratories, Inc.
1601 K St. NW
Washington,  DC  20006
Correspondent Contact SUZAN ONEL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/15/2010
Decision Date 11/18/2010
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
Recalls CDRH Recalls
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