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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 K102741
Device Name ENTERAL FEEDING BAG AND SETS
Applicant
Shandong Weigao Group Medical Polymer Co., Ltd.
P.O.Box 237-023
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Shandong Weigao Group Medical Polymer Co., Ltd.
P.O.Box 237-023
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/22/2010
Decision Date 11/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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