Device Classification Name |
system, dialysate delivery, central multiple patient
|
510(k) Number |
K052764 |
Device Name |
DIACAP ULTRA DIALYSIS FLUID FILTER |
Applicant |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
SCHWARZENBERGER WEG 73-79 |
MELSUNGEN,
DE
D-34212
|
|
Applicant Contact |
SCOTT J PEASE |
Correspondent |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
SCHWARZENBERGER WEG 73-79 |
MELSUNGEN,
DE
D-34212
|
|
Correspondent Contact |
SCOTT J PEASE |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 09/30/2005 |
Decision Date | 06/09/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|