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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 K161045
Device Name Monoject
15 hampshire street
mansfield,  MA  02048
Applicant Contact sona manickam
15 hampshire street
mansfield,  MA  02048
Correspondent Contact sona manickam
Regulation Number876.5980
Classification Product Code
Date Received04/13/2016
Decision Date 06/17/2016
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