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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, capillary, hollow fiber
510(k) Number K861537
Device Name ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5
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
FJI  
Date Received04/24/1986
Decision Date 07/10/1986
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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