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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 K872652
Device Name UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
Applicant
Travenol Laboratories, S.A.
Wilson Rd. At Rte. 120
P.O. Box 490
Round Lake,  IL  60073
Applicant Contact ROBERT L WILKINSON
Correspondent
Travenol Laboratories, S.A.
Wilson Rd. At Rte. 120
P.O. Box 490
Round Lake,  IL  60073
Correspondent Contact ROBERT L WILKINSON
Regulation Number876.5630
Classification Product Code
FKX  
Date Received07/07/1987
Decision Date 09/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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