Device Classification Name |
Media, Reproductive
|
510(k) Number |
K161261 |
Device Name |
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase |
Applicant |
Genea Biomedx Pty Ltd |
Level 2, 321 Kent Street |
Sydney,
AU
2000
|
|
Applicant Contact |
Kea Dent |
Correspondent |
Donawa Lifescience Consulting Srl |
Piazza Albania 10 |
00153 Rome,
IT
|
|
Correspondent Contact |
Roger Gray |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 05/04/2016 |
Decision Date | 05/12/2017 |
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
|
|
|