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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 K974902
Device Name JMS APHERESIS NEEDLE
Applicant
JMS CO., LTD.
12-17, KAKO-MACHI, NAKA-KU
HIROSHIMA,  JP 730-8652
Applicant Contact TETSUHARN HIROSE
Correspondent
JMS CO., LTD.
12-17, KAKO-MACHI, NAKA-KU
HIROSHIMA,  JP 730-8652
Correspondent Contact TETSUHARN HIROSE
Regulation Number876.5540
Classification Product Code
FIE  
Date Received12/30/1997
Decision Date 03/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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