Device Classification Name |
Tank, Holding, Dialysis
|
510(k) Number |
K060333 |
Device Name |
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM |
Applicant |
DIALYSIS SERVICES, INC. |
130 ELDER DR. |
SPRINGFIELD,
TN
37172
|
|
Applicant Contact |
MIKE STERLING |
Correspondent |
DIALYSIS SERVICES, INC. |
130 ELDER DR. |
SPRINGFIELD,
TN
37172
|
|
Correspondent Contact |
MIKE STERLING |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 02/09/2006 |
Decision Date | 09/08/2006 |
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
|
|
|