FDA 510(k) Applications Submitted by Li Hua
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210779 |
03/15/2021 |
Powder Free Nitrile Patient Examination Gloves, Blue Color |
Shandong Shangwei Medical Products Co.,Ltd |
| K210780 |
03/15/2021 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Shandong Shangwei Medical Products Co.,Ltd |
| K211454 |
05/10/2021 |
Surgical mask |
Jiangsu Xingtong Biotechnology Group Co., Ltd. |
| K213524 |
11/03/2021 |
CytonPro-5000 |
Cytonsys Inc |
| K212857 |
09/08/2021 |
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use |
Jiangsu Zhiyu Medical Instrument Co, Ltd. |
| K970315 |
01/27/1997 |
EVEREST SUNGLASSES |
YCC INTERNATIONAL CORP. |
| K170145 |
01/17/2017 |
Digital TENS Unit |
SHENZHEN EAPPLY TECHNOLOGY CO., LTD |
| K231865 |
06/26/2023 |
Mouth Guard (ATG0603R) |
Reazeal Corp |
| K220183 |
01/24/2022 |
Sterile Safety Syringes for Single Use (Retractable) |
Shanghai Kindly Enterprise Development Group Co., Ltd |
| K220185 |
01/24/2022 |
Sterile Safety Insulin Syringes for Single Use |
Shanghai Kindly Enterprise Development Group Co., Ltd. |
| K221416 |
05/16/2022 |
Sterile Safety Syringes for Single Use |
Shanghai Kindly Enterprise Development Group Co., Ltd |
| K223327 |
10/31/2022 |
Sterile Aesthetic Cannula and Hypodermic Needle |
Shanghai Kindly Enterprise Development Group Co., Ltd |
| K212972 |
09/17/2021 |
KDL Safety Needles |
Shanghai Kindly Enterprise Development Group Co., Ltd |
| K201153 |
04/30/2020 |
Tisuthes e-PTFE Surgical Patch |
Shanghai Suokang Medical Implants Co., Ltd. |
| K193264 |
11/26/2019 |
Disposable High Speed Air Turbine Handpiece |
Ningbo HPDOVE Dental Instruments Co., Ltd. |
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