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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 K253033
Device Name Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
Applicant
Simplivia Healthcare , Ltd.
North Industrial Zone, Eli Horovitz 1
P.O. Box 888
Kiryat Shmona,  IL 1101801
Applicant Contact Shay Shaham
Correspondent
Simplivia Healthcare , Ltd.
North 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 Received09/22/2025
Decision Date 10/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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