Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K070177 |
Device Name |
FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES |
Applicant |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 WINTER ST. |
WALTHAM,
MA
02451
|
|
Applicant Contact |
JANET C KAY |
Correspondent |
FRESENIUS MEDICAL CARE NORTH AMERICA |
920 WINTER ST. |
WALTHAM,
MA
02451
|
|
Correspondent Contact |
JANET C KAY |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 01/18/2007 |
Decision Date | 03/29/2007 |
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
|
|
|