Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K070189 |
Device Name |
ACCU-CHEK ULTRAFLEX INFUSION SET |
Applicant |
DISETRONIC MEDICAL SYSTEMS AG |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Applicant Contact |
MIKE FLIS |
Correspondent |
DISETRONIC MEDICAL SYSTEMS AG |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
MIKE FLIS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 01/22/2007 |
Decision Date | 02/21/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|