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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastrointestinal tubes with enteral specific connectors
510(k) Number K181276
Device Name CONOD Enteral Feeding Sets
Applicant
Conod Medical Co., Limited
No.38 Hongfeng Road, Baimao Industrial Park
Changshu,  CN 310002
Applicant Contact Cheng Run
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co.,Ltd.
9th Floor, R&D Building, No.26 Qinglan Street
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Mike Gu
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
KNT  
Date Received05/14/2018
Decision Date 07/12/2018
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
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