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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Line
510(k) Number K854517
Device Name NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact BRIAN STEMBAL
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact BRIAN STEMBAL
Regulation Number876.4730
Classification Product Code
FKK  
Date Received11/12/1985
Decision Date 12/02/1985
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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