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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K883748
Device Name RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS
Applicant
Kawasumi Laboratories Co., Ltd.
Kawasumi Bldg. 3-28-15
Minami-Ohi, Shinagawa-Ku
Tokyo,  JP 140
Applicant Contact KENJIRO TANI
Correspondent
Kawasumi Laboratories Co., Ltd.
Kawasumi Bldg. 3-28-15
Minami-Ohi, Shinagawa-Ku
Tokyo,  JP 140
Correspondent Contact KENJIRO TANI
Regulation Number876.5820
Classification Product Code
FJI  
Date Received09/01/1988
Decision Date 01/31/1989
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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