Device Classification Name |
dialysate concentrate for hemodialysis (liquid or powder)
|
510(k) Number |
K072760 |
Device Name |
SOLCART B |
Applicant |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
901 MARCON BOULEVARD |
ALLENTOWN,
PA
18109 -9341
|
|
Applicant Contact |
TRACY MADDOCK |
Correspondent |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
901 MARCON BOULEVARD |
ALLENTOWN,
PA
18109 -9341
|
|
Correspondent Contact |
TRACY MADDOCK |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 09/28/2007 |
Decision Date | 01/29/2008 |
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
|
|
|