Device Classification Name |
accessories, blood circuit, hemodialysis
|
510(k) Number |
K230514 |
Device Name |
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series |
Applicant |
Nikkiso Co., Ltd. |
20-3, Ebisu 4-Chome |
Shibuya-ku,
JP
150-6022
|
|
Applicant Contact |
Satoko Hina |
Correspondent |
MIC International |
4-32-16 Ryogoku |
Sumida-ku,
JP
130-0023
|
|
Correspondent Contact |
Fumiaki Kanai |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 02/24/2023 |
Decision Date | 06/16/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|