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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 K171857
Device Name AMSure® Enteral Feeding Syringe with ENFit Tip
Applicant
Amsino International, Inc.
708 Corporate Center Dr.
Pomona,  CA  91768
Applicant Contact Cathy Hong
Correspondent
Amsino International, Inc.
708 Corporate Center Dr.
Pomona,  CA  91768
Correspondent Contact Cathy Hong
Regulation Number876.5980
Classification Product Code
PNR  
Date Received06/21/2017
Decision Date 03/30/2018
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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