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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K222889
Device Name FlowArt® Needle-Free Split Septum Valve
Applicant
Asset Medikal Tasarim San Tic As.
Ikitelli OSB Mahallesi, 17. Cadde, No: 17, Basaksehir
Istanbul,  TR 34490
Applicant Contact Ebru Sirali
Correspondent
Licensale Inc
3422 Leonardo Lane
New Myrna Beach,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/23/2022
Decision Date 01/20/2023
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
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