Device Classification Name |
media, reproductive
|
510(k) Number |
K200408 |
Device Name |
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium |
Applicant |
Shenzhen VitaVitro Biotech Co.,Ltd. |
R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No. 16 |
Shenzhen,
CN
518118
|
|
Applicant Contact |
Donghai Pan |
Correspondent |
Shenzhen VitaVitro Biotech Co., Ltd. |
R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No. 16 |
Shenzhen,
CN
518118
|
|
Correspondent Contact |
Donghai Pan |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 02/19/2020 |
Decision Date | 10/16/2020 |
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
|
|
|