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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, fistula
510(k) Number K142564
Device Name JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
Applicant
JMS North America Corporation
22320 Foothill Blvd., Suite 350
Hayward,  CA  94541
Applicant Contact Sho Hosoki
Correspondent
JMS North America Corporation
22320 Foothill Blvd., Suite 350
Hayward,  CA  94541
Correspondent Contact Sho Hosoki
Regulation Number876.5540
Classification Product Code
FIE  
Subsequent Product Code
FOZ  
Date Received09/11/2014
Decision Date 12/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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