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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 K010406
Device Name JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
Applicant
Jms Co., Ltd.
12-17, Kako-Machi, Naka-Ku
Hiroshima,  JP 730-8652
Applicant Contact KEISUKE URATOMI
Correspondent
Jms Co., Ltd.
12-17, Kako-Machi, Naka-Ku
Hiroshima,  JP 730-8652
Correspondent Contact KEISUKE URATOMI
Regulation Number880.5200
Classification Product Code
FOZ  
Subsequent Product Code
FIE  
Date Received02/12/2001
Decision Date 06/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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