Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K130468 |
Device Name |
ORBIT INFUSION SET |
Applicant |
YPSOMED AG |
BRUNNMATTSTRASSE 6 |
BURGDORF,
CH
CH-3401
|
|
Applicant Contact |
BENJAMIN REINMANN |
Correspondent |
YPSOMED AG |
BRUNNMATTSTRASSE 6 |
BURGDORF,
CH
CH-3401
|
|
Correspondent Contact |
BENJAMIN REINMANN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/25/2013 |
Decision Date | 03/19/2013 |
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
|
|
|