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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., # 101
Canoga Park,  CA  91303
Applicant Contact MARK A O'BRIEN
Correspondent
Kawasumi Laboratories Co., Ltd.
21515 Vanowen St., # 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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