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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
510(k) Number K241988
Device Name ProSeal™ Closed System Bag Access
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
ONB  
Subsequent Product Code
LHI  
Date Received07/08/2024
Decision Date 10/23/2024
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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