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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 K102890
Device Name K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)
Applicant
Kawasumi Laboratories America, Inc.
4723 Oak Fair Blvd.
Tampa,  FL  33610
Applicant Contact JACK PAVLO
Correspondent
Kawasumi Laboratories America, Inc.
4723 Oak Fair Blvd.
Tampa,  FL  33610
Correspondent Contact JACK PAVLO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/30/2010
Decision Date 10/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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