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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 K223674
Device Name eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
Applicant
Epic Medical Pte. , Ltd.
105 Cecil , 20-01 The Octagon
Singapore,  SG 069534
Applicant Contact Freddie Lee
Correspondent
Epic Medical Pte. , Ltd.
105 Cecil , 20-01 The Octagon
Singapore,  SG 069534
Correspondent Contact Freddie Lee
Regulation Number880.5025
Classification Product Code
KPE  
Date Received12/07/2022
Decision Date 09/01/2023
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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