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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 K900018
Device Name HOLLOW FIBER DIALYZER, BIO CARE PS 130
Applicant
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
TWO VOLVO DR.
ROCKLEIGH,  NJ  07647
Applicant Contact JOHN R TREMBLEY
Correspondent
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
TWO VOLVO DR.
ROCKLEIGH,  NJ  07647
Correspondent Contact JOHN R TREMBLEY
Regulation Number876.5860
Classification Product Code
KDI  
Date Received01/02/1990
Decision Date 07/27/1990
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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