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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Syringes With Enteral Specific Connectors
510(k) Number K203410
Device Name ENFit Disposable Enteral Syringe
Applicant
Shantou Wealy Medical Instrument Co.,Ltd
North Jinhuan Rd. (Near Qishan Mid-School),
Shantou China
Shantou,  CN 515064
Applicant Contact Yang Songling
Correspondent
Shanghai Sungo Management Consulting Company Limited.
Rm. 1309, Dongfang Bldg., 1500# Century Ave.,
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number876.5980
Classification Product Code
PNR  
Date Received11/19/2020
Decision Date 06/28/2021
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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