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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, For Peritoneal Dialysis, Disposable
510(k) Number K870145
Device Name EXTERNAL Y VALVE 5C4198
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 Number876.5630
Classification Product Code
KDJ  
Date Received01/13/1987
Decision Date 03/10/1987
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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