Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K100334 |
Device Name |
DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 |
Applicant |
B. BRAUN AVITUM AG |
901 MARCON BOULEVARD |
ALLENTOWN,
PA
18109
|
|
Applicant Contact |
ANGELA J CARAVELLA |
Correspondent |
B. BRAUN AVITUM AG |
901 MARCON BOULEVARD |
ALLENTOWN,
PA
18109
|
|
Correspondent Contact |
ANGELA J CARAVELLA |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 02/05/2010 |
Decision Date | 04/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|