Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K010131 |
Device Name |
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB |
Applicant |
AKSYS, LTD. |
TWO MARRIOTT DR. |
LINCOLNSHIRE,
IL
60069 -3700
|
|
Applicant Contact |
JAN L ZORN |
Correspondent |
AKSYS, LTD. |
TWO MARRIOTT DR. |
LINCOLNSHIRE,
IL
60069 -3700
|
|
Correspondent Contact |
JAN L ZORN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 01/16/2001 |
Decision Date | 03/26/2002 |
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
|
|
|