FDA 510(k) Applications Submitted by Dong Guk Ha
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150537 |
03/03/2015 |
MiNi Internal Implant System |
MEGAGEN IMPLANT CO., LTD |
| K230102 |
01/13/2023 |
Smart double sides wearable breast pump, Electric bilateral breast pump |
Huizhou LVB Maternal And Infant Supplies Co,Ltd. |
| K241004 |
04/12/2024 |
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) |
HuiZhou LVB Maternal and Infant Supplies Co., Ltd. |
| K192561 |
09/17/2019 |
TRAUS SUS20 |
Saeshin Precision Co., Ltd. |
| K240307 |
02/02/2024 |
VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) |
Shenzhen VitaVitro Biotech Co., Ltd. |
| K200408 |
02/19/2020 |
VitaVitro« Fertilization Medium, VitaVitro« Gamete Buffer Medium, VitaVitro« Flushing Buffer Medium |
Shenzhen VitaVitro Biotech Co.,Ltd. |
| K240523 |
02/23/2024 |
VitaVitro« Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro« Double Lumen Oocyte Retrieval Needle (ORND-17G) |
Shenzhen VitaVitro Biotech Co., Ltd. |
| K191063 |
04/22/2019 |
1-Step Culture Medium |
Shenzhen VitaVitro Biotech Co., Ltd. |
| K212410 |
08/03/2021 |
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium |
Shenzhen VitaVitro Biotech Co.,Ltd. |
| K232992 |
09/22/2023 |
10THERMA |
Tentech Inc. |
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