The following data is part of a premarket notification filed by Shenzhen Vitavitro Bio-tech Co., Ltd with the FDA for Vitavitro Vitrification Kit, Vitavitro Warming Kit, And Vitavitro Straw Set.
| Device ID | K180073 |
| 510k Number | K180073 |
| Device Name: | Vitavitro Vitrification Kit, Vitavitro Warming Kit, And Vitavitro Straw Set |
| Classification | Media, Reproductive |
| Applicant | Shenzhen Vitavitro Bio-tech Co., Ltd R601, Building B, Hai Ke Xing Tech Park Baoshan Road No. 16 Shenzhen, CN 518118 |
| Contact | Jenny Lin |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road , Nanshan District Shenzhen, CN 518000 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-09 |
| Decision Date | 2018-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971982050021 | K180073 | 000 |
| 06971982050014 | K180073 | 000 |
| 06971982050007 | K180073 | 000 |