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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 K812802
Device Name CAPD U.V. GERMICIDAL CONNECTION SYSTEM
Applicant
Travenol Laboratories, S.A.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Travenol Laboratories, S.A.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received10/06/1981
Decision Date 03/02/1982
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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