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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, for peritoneal dialysis, disposable
510(k) Number K900226
Device Name DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6
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 Number876.5630
Classification Product Code
KDJ  
Date Received01/17/1990
Decision Date 03/22/1990
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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