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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 K952343
Device Name FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
Applicant
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
2 VOLVO DR.
ROCKLEIGH,  NJ  07647
Applicant Contact DEBRA L BING
Correspondent
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
2 VOLVO DR.
ROCKLEIGH,  NJ  07647
Correspondent Contact DEBRA L BING
Regulation Number876.5820
Classification Product Code
FJI  
Subsequent Product Code
KDI  
Date Received05/19/1995
Decision Date 12/22/1995
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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