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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 K850406
Device Name AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM
Applicant
TRAVENOL LABORATORIES, S.A.
deerfield,  IL  60015
Applicant Contact julia a meyer
Correspondent
TRAVENOL LABORATORIES, S.A.
deerfield,  IL  60015
Correspondent Contact julia a meyer
Regulation Number876.5630
Classification Product Code
FKX  
Date Received02/04/1985
Decision Date 02/21/1985
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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