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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 K192866
Device Name Chemfort CSTD
Applicant
Simplivia Healthcare , Ltd.
North Industrial Zone
Kiryat Shmona,  IL 1101801
Applicant Contact Itsik Shmueli
Correspondent
Donawa Lifescience Consulting
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number880.5440
Classification Product Code
ONB  
Date Received10/07/2019
Decision Date 05/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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