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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 K860230
Device Name CAPD TRANSFER SET SPIKE 5C4363
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
KDJ  
Date Received01/22/1986
Decision Date 02/05/1986
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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