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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 K192075
Device Name ProSeal™ Closed System drug Transfer Device (CSTD)
Applicant
Epic Medical Pte. , Ltd.
10 Jalan Besar, #06-04, Sim Lim Tower
Singapore,  SG 208787
Applicant Contact Freddie Lee
Correspondent
G&L Scientific, Inc.
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Roshana Ahmed
Regulation Number880.5440
Classification Product Code
ONB  
Date Received08/02/2019
Decision Date 08/07/2020
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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