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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 K851975
Device Name ENTERAL FEEDING BAG, 1000 ML, & TUBING SET
Applicant
Venusa , Ltd.
95 Newfield Ave.
Raritan Center
Edison,  NJ  08837
Applicant Contact RONALD J GUIDA
Correspondent
Venusa , Ltd.
95 Newfield Ave.
Raritan Center
Edison,  NJ  08837
Correspondent Contact RONALD J GUIDA
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/07/1985
Decision Date 09/05/1985
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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