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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Enteral
510(k) Number K220230
Device Name AMSure Enteral Feeding Pump
Applicant
Amsino International Inc.
708 Corporate Center Drive
Pomona,  CA  91768
Applicant Contact Jane Gao
Correspondent
Amsino International Inc.
708 Corporate Center Drive
Pomona,  CA  91768
Correspondent Contact Jane Gao
Regulation Number880.5725
Classification Product Code
LZH  
Date Received01/27/2022
Decision Date 11/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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