Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K071387 |
Device Name |
FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street |
Waltham,
MA
02451
|
|
Applicant Contact |
JANET C KAY |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street |
Waltham,
MA
02451
|
|
Correspondent Contact |
JANET C KAY |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 05/18/2007 |
Decision Date | 06/15/2007 |
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
|
Recalls |
CDRH Recalls
|