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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, tubing, blood, with and without anti-regurgitation valve
510(k) Number K920797
Device Name HEMODIALYSIS BLOOD TUBING SET
Applicant
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
TWO VOLVO DR.
ROCKLEIGH,  NJ  07647
Applicant Contact MATTHEWS, SR
Correspondent
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
TWO VOLVO DR.
ROCKLEIGH,  NJ  07647
Correspondent Contact MATTHEWS, SR
Regulation Number876.5820
Classification Product Code
FJK  
Date Received02/21/1992
Decision Date 09/21/1992
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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