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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 K201142
Device Name TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set
Applicant
Simplivia Healthcare , Ltd.
North Industrial Zone
Kiryat Shmona,  IL 1011801
Applicant Contact Shay Shaham
Correspondent
Simplivia Healthcare , Ltd.
North Industrial Zone
Kiryat Shmona,  IL 1011801
Correspondent Contact Shay Shaham
Regulation Number880.5440
Classification Product Code
ONB  
Subsequent Product Code
FPA  
Date Received04/29/2020
Decision Date 02/25/2021
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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