Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K990010 |
Device Name |
ALTHIN MEDICAL AB ALTRACART II |
Applicant |
ALTHIN MEDICAL AB |
BOX 39, (FRIDHEMSV. 15) |
372 21 RONNEBY,
SE
372 21
|
|
Applicant Contact |
ULF LUNDGREN |
Correspondent |
ALTHIN MEDICAL AB |
BOX 39, (FRIDHEMSV. 15) |
372 21 RONNEBY,
SE
372 21
|
|
Correspondent Contact |
ULF LUNDGREN |
Regulation Number | 876.5820 |
Classification Product Code |
|
Date Received | 01/04/1999 |
Decision Date | 04/15/1999 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|