Device Classification Name |
Media, Reproductive
|
510(k) Number |
K202862 |
Device Name |
Gx-IVF, Gx-TL, Gx-MOPS PLUS |
Applicant |
Vitrolife Sweden AB |
Gustaf Werners gata 2 |
Vastra Frolunda,
SE
42132
|
|
Applicant Contact |
Sarah Hood Hagberg |
Correspondent |
Vitrolife Sweden AB |
Gustaf Werners gata 2 |
Vastra Frolunda,
SE
42132
|
|
Correspondent Contact |
Sarah Hood Hagberg |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 09/28/2020 |
Decision Date | 05/14/2021 |
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
|
|
|