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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 K202748
Device Name Enteral Feeding Catheter
Applicant
Medcaptain Life Science Co., Ltd.
601, Bldg. C, Jinweiyuan Industrial Park, Pingshan Distri
Shenzhen,  CN 518118
Applicant Contact David Xia
Correspondent
Medcaptain Life Science Co., Ltd.
601, Bldg. C, Jinweiyuan Industrial Park, Pingshan Distri
Shenzhen,  CN 518118
Correspondent Contact David Xia
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/21/2020
Decision Date 04/09/2021
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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