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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K861618
Device Name TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact ROBERT WILKINSON
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact ROBERT WILKINSON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/29/1986
Decision Date 07/15/1986
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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