Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K001250 |
Device Name |
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) |
Applicant |
ASAHI MEDICAL CO., LTD. |
1801 ROCKVILLE PIKE PIKE |
SUITE 300 |
ROCKVILLE,
MD
20852
|
|
Applicant Contact |
DAVID L WEST |
Correspondent |
ASAHI MEDICAL CO., LTD. |
1801 ROCKVILLE PIKE PIKE |
SUITE 300 |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
DAVID L WEST |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 04/19/2000 |
Decision Date | 08/16/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|