Device Classification Name |
tank, holding, dialysis
|
510(k) Number |
K030366 |
Device Name |
BICARD MIXING SYSTEM |
Applicant |
DIALYSIS SYSTEMS, INC. |
2003 BLAIR BLVD. |
NASHVILLE,
TN
37212
|
|
Applicant Contact |
MARK VESLIGAJ |
Correspondent |
DIALYSIS SYSTEMS, INC. |
2003 BLAIR BLVD. |
NASHVILLE,
TN
37212
|
|
Correspondent Contact |
MARK VESLIGAJ |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 02/04/2003 |
Decision Date | 04/19/2004 |
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
|
|
|