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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 K970962
Device Name JMS AV FISTULA NEEDLE
Applicant
Jms Co., Ltd.
12,17,Kako-Machi,Naka-Ku
Hiroshima, 730,  JP
Applicant Contact T HIROSE
Correspondent
Jms Co., Ltd.
12,17,Kako-Machi,Naka-Ku
Hiroshima, 730,  JP
Correspondent Contact T HIROSE
Regulation Number876.5540
Classification Product Code
FIE  
Date Received03/17/1997
Decision Date 08/07/1997
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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