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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 K251411
Device Name Chemfort Female Luer Lock Adaptor
Applicant
Simplivia Healthcare , Ltd.
Kiryat Shmona, N. Industrial Zone, Eli Horovitz 1
P.O. Box 888
Kiryat Shmona,  IL 1101801
Applicant Contact Shay Shaham
Correspondent
Simplivia Healthcare , Ltd.
Kiryat Shmona, N. Industrial Zone, Eli Horovitz 1
P.O. Box 888
Kiryat Shmona,  IL 1101801
Correspondent Contact Shay Shaham
Regulation Number880.5440
Classification Product Code
ONB  
Date Received05/07/2025
Decision Date 08/05/2025
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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