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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K030479
Device Name JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET
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 Number880.5200
Classification Product Code
FOZ  
Date Received02/13/2003
Decision Date 08/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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