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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 K874084
Device Name MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
Applicant
National Medical Care, Medical Products Div., Inc.
Two Volvo Dr.
Rockleigh,  NJ  07647
Applicant Contact DEL DONNA
Correspondent
National Medical Care, Medical Products Div., Inc.
Two Volvo Dr.
Rockleigh,  NJ  07647
Correspondent Contact DEL DONNA
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received10/07/1987
Decision Date 04/27/1988
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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