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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 K842885
Device Name EXTENDED LIFE CAPD SOLUTION TRANSFER
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 Received07/23/1984
Decision Date 10/18/1984
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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