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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
#38 Hongfeng Rd., Baimao Industrial Park
Changshu,  CN 310002
Applicant Contact Cheng Run
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
9th Floor, R&D Bldg., # 26 Qinglan St.
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
Predetermined Change
Control Plan Authorized		 No
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