Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K150921 |
Device Name |
Orbit Infusion Set |
Applicant |
YPSOMED AG |
BRUNNMATTSTRASSE 6 |
BURGDORF,
CH
CH-3401
|
|
Applicant Contact |
STEPHAN AFFOLTER |
Correspondent |
P/L BIOMEDICAL |
10882 STONINGTON AVENUE. |
FORT MYERS,
FL
33913
|
|
Correspondent Contact |
LEE LEICHTER |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/06/2015 |
Decision Date | 04/12/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|