Device Classification Name |
catheter, nephrostomy
|
510(k) Number |
K222705 |
Device Name |
Introducer Needle |
Applicant |
YouCare Technology Co., Ltd. (Wuhan) |
Great Wall Science and Technology Park |
East Lake Development Zone, Wuhan |
Wuhan,
CN
|
|
Applicant Contact |
Bing Hu |
Correspondent |
YouCare Technology Co., Ltd. (Wuhan) |
Great Wall Science and Technology Park |
East Lake Development Zone, Wuhan |
Wuhan,
CN
|
|
Correspondent Contact |
Bing Hu |
Classification Product Code |
|
Date Received | 09/07/2022 |
Decision Date | 05/22/2023 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|