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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K102994
Device Name K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
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 Number880.5570
Classification Product Code
FMI  
Date Received10/08/2010
Decision Date 11/03/2010
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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