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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Dialysate Level
510(k) Number K883490
Device Name ACCUFLO UF CONTROL MODULE NO. 74-0100-3
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
FJB  
Date Received08/16/1988
Decision Date 09/29/1988
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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