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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K252094
Device Name eZSURE™ Empty Fluid Container
Applicant
Epic Medical Pte. , Ltd.
105 Cecil St. #20-04, The Octagon
Singapore,  SG 069534
Applicant Contact Freddie Lee
Correspondent
Epic Medical Pte. , Ltd.
105 Cecil St. #20-04, The Octagon
Singapore,  SG 069534
Correspondent Contact Freddie Lee
Regulation Number880.5025
Classification Product Code
KPE  
Subsequent Product Code
ONB  
Date Received07/03/2025
Decision Date 08/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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