Device Classification Name |
labware, assisted reproduction
|
510(k) Number |
K213869 |
Device Name |
EmbryoSlide+ ic8 dish |
Applicant |
Vitrolife A/S |
Jens Juuls Vej 20 |
Viby J,
DK
8260
|
|
Applicant Contact |
Belinda Dueholm |
Correspondent |
Vitrolife A/S |
Jens Juuls Vej 20 |
Viby J,
DK
8260
|
|
Correspondent Contact |
Belinda Dueholm |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 12/13/2021 |
Decision Date | 03/11/2022 |
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
|
|
|