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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, tubing, blood, with and without anti-regurgitation valve
510(k) Number K032975
Device Name JMS BLOOD TUBING SETS
Applicant
JMS NORTH AMERICA CORP.
22320 FOOTHILL BLVD.,
SUITE 350
HAYWARD,  CA  94541
Applicant Contact SWEE CHEAU
Correspondent
JMS NORTH AMERICA CORP.
22320 FOOTHILL BLVD.,
SUITE 350
HAYWARD,  CA  94541
Correspondent Contact SWEE CHEAU
Regulation Number876.5820
Classification Product Code
FJK  
Subsequent Product Code
KOC  
Date Received09/24/2003
Decision Date 08/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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