Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K101196 |
Device Name |
ACCU-CHEK ULTRFLEX INFUSION SET |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
Scott Thiel |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
Scott Thiel |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/29/2010 |
Decision Date | 08/27/2010 |
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
|
|
|