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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 K210621
Device Name Oral/Enteral Syringe
Applicant
Ningbo Tianyi Medical Appliance Co., Ltd.
#788, Mozhi N. Rd., Tourism Resort, Dongqian Lake
Ningbo,  CN 315121
Applicant Contact Wenyu Zhang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number876.5980
Classification Product Code
PNR  
Date Received03/02/2021
Decision Date 04/28/2021
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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