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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
Original Applicant
KAWASUMI LABORATORIES, INC.
1601 k street, n.w.
washington,  DC  20006
Original 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
Recalls CDRH Recalls
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