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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, dialysate delivery, sealed
510(k) Number K872364
Device Name HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
Applicant
TRAVENOL LABORATORIES, S.A.
WILSON RD. AT ROUTE 120
P.O. BOX 490
ROUND LAKE,  IL  60073
Applicant Contact ROBERT L WILKINSON
Correspondent
TRAVENOL LABORATORIES, S.A.
WILSON RD. AT ROUTE 120
P.O. BOX 490
ROUND LAKE,  IL  60073
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5860
Classification Product Code
FII  
Date Received06/18/1987
Decision Date 10/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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