Device Classification Name |
System, Dialysate Delivery, Central Multiple Patient
|
510(k) Number |
K852749 |
Device Name |
RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT |
Applicant |
MESA MEDICAL, INC. |
3904 YOUNGFIELD ST. |
WHEAT RIDGE,
CO
80033
|
|
Applicant Contact |
PAUL D DUKE |
Correspondent |
MESA MEDICAL, INC. |
3904 YOUNGFIELD ST. |
WHEAT RIDGE,
CO
80033
|
|
Correspondent Contact |
PAUL D DUKE |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 06/27/1985 |
Decision Date | 09/10/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|