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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Central Multiple Patient
510(k) Number K873421
Device Name KAWASUMI A.V. FISTULA SET
Applicant
KAWASUMI LABORATORIES CO., LTD.
21515 VANOWEN ST., NO. 101
CANOGA PARK,  CA  91303
Applicant Contact MARK A O'BRIEN
Correspondent
KAWASUMI LABORATORIES CO., LTD.
21515 VANOWEN ST., NO. 101
CANOGA PARK,  CA  91303
Correspondent Contact MARK A O'BRIEN
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received08/25/1987
Decision Date 10/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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