Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K190806 |
Device Name |
Flowart |
Applicant |
ASSET MEDIKAL TASARIM A.S. |
Marmara San. Sit. M Blok No: 7-A, Ikitelli Kucukcekmece |
Istanbul,
TR
34303
|
|
Applicant Contact |
Ebru Sirali |
Correspondent |
Licensale Inc |
3422 Leonardo Lane |
New Myrna Beach,
FL
32168
|
|
Correspondent Contact |
Raymond Kelly |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/29/2019 |
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
|
|
|