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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 K181426
Device Name Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
Applicant
Jiangsu Micsafe Medical Technology Co., Ltd.
Xituan Industrial Park, Dafeng District
Yancheng,  CN 224125
Applicant Contact Tony Yang
Correspondent
Wenzhou Cytech Information Service Co., Ltd.
Rm.302, Bldg. 3, Hangqian St.
Lucheng District
Wenzhou,  CN 325000
Correspondent Contact Helen Nan
Regulation Number876.5980
Classification Product Code
PNR  
Date Received05/31/2018
Decision Date 10/11/2018
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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