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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K844280
Device Name TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
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 Number876.5250
Classification Product Code
KNX  
Date Received11/05/1984
Decision Date 12/17/1984
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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