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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 K193657
Device Name Disposable Enteral Feeding Syringe with Enfit Connector
Applicant
Shinva Ande Healthcare Apparatus Co., Ltd.
#77 Development Zone N. Rd.,
Zibo,  CN 255086
Applicant Contact Xiaolei Tian
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Bldg., # 26 Quinglan St.,
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Mike Gu
Regulation Number876.5980
Classification Product Code
PNR  
Date Received12/30/2019
Decision Date 09/12/2020
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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