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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 K190806
Device Name Flowart
Applicant
Asset Medikal Tasarim As.
Marmara San. Sit. M Blok No: 7-A, Ikitelli Kucukcekmece
Istanbul,  TR 34303
Applicant Contact Ebru Sirali
Correspondent
Licensale, Inc.
3422 Leonardo Lane
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/29/2019
Decision Date 02/20/2020
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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