Device Classification Name |
Media, Reproductive
|
510(k) Number |
K180073 |
Device Name |
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set |
Applicant |
Shenzhen Vitavitro Bio-tech Co., Ltd |
R601, Building B, Hai Ke Xing Tech Park |
Baoshan Road No. 16 |
Shenzhen,
CN
518118
|
|
Applicant Contact |
Jenny Lin |
Correspondent |
Shenzhen Joyantech Consulting Co., Ltd |
NO. 55 Shizhou middle road , Nanshan District |
Shenzhen,
CN
518000
|
|
Correspondent Contact |
Field Fu |
Regulation Number | 884.6180
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/09/2018 |
Decision Date | 08/29/2018 |
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
|
|
|