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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, peritoneal, automatic delivery
510(k) Number K905809
Device Name NMC CYCLER MACHINE
Applicant
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
TWO VOLVO DR.
ROCKLEIGH,  NJ  07647
Applicant Contact WILLIAM R MATTHEWS
Correspondent
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
TWO VOLVO DR.
ROCKLEIGH,  NJ  07647
Correspondent Contact WILLIAM R MATTHEWS
Regulation Number876.5630
Classification Product Code
FKX  
Date Received12/27/1990
Decision Date 02/25/1992
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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