Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K052393 |
Device Name |
B. BRAUN MODIFIED BICARBONATE DIALYSATE |
Applicant |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109 -9341
|
|
Applicant Contact |
CHRISTINE FORD |
Correspondent |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109 -9341
|
|
Correspondent Contact |
CHRISTINE FORD |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 08/31/2005 |
Decision Date | 11/09/2005 |
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
|
|
|