Device Classification Name |
media, reproductive
|
510(k) Number |
K172197 |
Device Name |
SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS |
Applicant |
ORIGIO a/s |
Knardrupvej 2 |
Malov,
DK
2760
|
|
Applicant Contact |
Tove Kjaer |
Correspondent |
ORIGIO a/s |
Knardrupvej 2 |
Malov,
DK
2760
|
|
Correspondent Contact |
Tove Kjaer |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 07/21/2017 |
Decision Date | 10/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|