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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 K060580
Device Name K-SHIELD PORT ACCESS INFUSION SET
Applicant
KAWASUMI LABORATORIES, INC.
4723 OAK FAIR BLVD
TAMPA,  FL  33610
Applicant Contact JACK PAVLO
Correspondent
KAWASUMI LABORATORIES, INC.
4723 OAK FAIR BLVD
TAMPA,  FL  33610
Correspondent Contact JACK PAVLO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/06/2006
Decision Date 06/06/2006
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
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