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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, Elastomeric
510(k) Number K250234
Device Name SMARTeZ™ Elastomeric Infusion Pump (RS series)
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 Number880.5725
Classification Product Code
MEB  
Date Received01/27/2025
Decision Date 04/24/2026
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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