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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 K990470
FOIA Releasable 510(k) K990470
Device Name JMS A. V. FISTULA NEEDLE SET
Applicant
JMS CO., LTD.
12-17, KAKO-MACHI, NAKA-KU
HIROSHIMA,  JP 730-8652
Applicant Contact TETSUHARU HIROSE
Correspondent
JMS CO., LTD.
12-17, KAKO-MACHI, NAKA-KU
HIROSHIMA,  JP 730-8652
Correspondent Contact TETSUHARU HIROSE
Regulation Number876.5540
Classification Product Code
FIE  
Date Received02/16/1999
Decision Date 08/30/1999
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
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