The following data is part of a premarket notification filed by Donnevie Medical Technology (shanghai) Co. Ltd. with the FDA for Dewin Reproductive Media (dewin Fertilization Medium [with Hsa And Without Hsa] And Dewin Cleavage Medium [with Hsa And Without Hsa]).
| Device ID | K212426 |
| 510k Number | K212426 |
| Device Name: | Dewin Reproductive Media (Dewin Fertilization Medium [with HSA And Without HSA] And Dewin Cleavage Medium [with HSA And Without HSA]) |
| Classification | Media, Reproductive |
| Applicant | DonneVie Medical Technology (Shanghai) Co. Ltd. Suite 201, Bld 1, 138 Xinjun Ring Shanghai, CN 201114 |
| Contact | Hannah Hang Yin |
| Correspondent | Stuart R. Goldman Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2022-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972962312443 | K212426 | 000 |
| 06972962312467 | K212426 | 000 |
| 06972962312450 | K212426 | 000 |
| 06972962312436 | K212426 | 000 |
| 06972962312184 | K212426 | 000 |
| 06972962312177 | K212426 | 000 |
| 06972962312160 | K212426 | 000 |
| 06972962312153 | K212426 | 000 |