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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K252987
Device Name ADRx™ Admixture Device
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 Number880.5440
Classification Product Code
LHI  
Date Received09/18/2025
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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