Device Classification Name |
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
|
510(k) Number |
K223208 |
Device Name |
Safety Lancet |
Applicant |
Suzhou Zhenwu Medical Co., Ltd. |
No. 248, Chijiawan Road, Wujiang District, Suzhou City, |
Suzhou,
CN
215214
|
|
Applicant Contact |
Kai Xu |
Correspondent |
Shanghai Mind-link Consulting Co., Ltd. |
1399 Jiangyue Road, Minhang |
Shanghai,
CN
201114
|
|
Correspondent Contact |
Evan Hu |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 10/17/2022 |
Decision Date | 02/10/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|