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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, for peritoneal dialysis, disposable
510(k) Number K892871
Device Name PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD
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 Number876.5630
Classification Product Code
KDJ  
Date Received04/19/1989
Decision Date 05/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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