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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K914363
Device Name PERITONEAL DIALYSIS CYCLER SET
Applicant
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
TWO VOLVO DR.
ROCKLEIGH,  NJ  07647
Applicant Contact ROBERT BISHOP
Correspondent
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
TWO VOLVO DR.
ROCKLEIGH,  NJ  07647
Correspondent Contact ROBERT BISHOP
Regulation Number876.5860
Classification Product Code
KDI  
Date Received10/01/1991
Decision Date 03/16/1992
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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