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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K232987
Device Name FlowArt Valve for Vial Access
Applicant
Asset Medikal Tasarim Sanayi Ve Ticaret A.S.
Ikitelli OSB Mah., 17. Cd, No:17 Basaksehir
Istanbul,  TR 34303
Applicant Contact Ebru Sirali
Correspondent
Licensale Inc
3422 Leonardo Lane
New Smyrna Beach,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.5440
Classification Product Code
LHI  
Date Received09/22/2023
Decision Date 06/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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