Device Classification Name |
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
|
510(k) Number |
K223313 |
Device Name |
Disposable Safety Lancets |
Applicant |
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD |
No. 6 West Hongdou Road Economic Development Zone |
Huaian,
CN
|
|
Applicant Contact |
Zhengcan Da |
Correspondent |
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD |
No. 6 West Hongdou Road Economic Development Zone |
Huaian,
CN
|
|
Correspondent Contact |
Zhengcan Da |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 10/28/2022 |
Decision Date | 01/23/2023 |
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
|