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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 K201872
Device Name NeutrArt
Applicant
Asset Medikal Tasarim As.
Ikitelli Osb Mahallesi, 17. Cadde, No: 17
Istanbul,  TR 34490
Applicant Contact Ebru Sirali
Correspondent
Licensale, Inc.
3422 Leonardo Ln.
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FMG  
Date Received07/07/2020
Decision Date 01/05/2021
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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