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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 K791899
FOIA Releasable 510(k) K791899
Device Name CYCLER SETS MOD. #5C4143, 5C4144, 5C4145
Applicant
Travenol Laboratories, S.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Travenol Laboratories, S.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received09/25/1979
Decision Date 11/13/1979
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
Recalls CDRH Recalls
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