FDA 510(k) Application Details - K190806

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K190806
Device Name	Set, Administration, Intravascular
Applicant	ASSET MEDIKAL TASARIM A.S. Marmara San. Sit. M Blok No: 7-A, Ikitelli Kucukcekmece Istanbul 34303 TR Other 510(k) Applications for this Company
Contact	Ebru Sirali Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2019
Decision Date	02/20/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review