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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 K190502
Device Name ENFit Oral / Enteral Syringe
Applicant
Jiangsu Caina Medical Co., Ltd.
No. 23, Huanxi Rd. Zhutang Town
Jiangyin City,  CN 214425
Applicant Contact Xinyan Ruan
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 Received03/01/2019
Decision Date 08/06/2019
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
Recalls CDRH Recalls
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