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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 K161963
Device Name Monoject Enteral Syringe with ENFit Connector
Applicant
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact SONA MANICKAM
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact SONA MANICKAM
Regulation Number876.5980
Classification Product Code
PNR  
Date Received07/18/2016
Decision Date 09/01/2016
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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