Device Classification Name |
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
|
510(k) Number |
K233796 |
Device Name |
Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) |
Applicant |
SteriLance Medical (Suzhou) Inc. |
No.168 PuTuoShan Road |
New District |
Suzhou,
CN
215153
|
|
Applicant Contact |
Susan Sun |
Correspondent |
SteriLance Medical (Suzhou) Inc. |
No.168 PuTuoShan Road |
New District |
Suzhou,
CN
215153
|
|
Correspondent Contact |
Susan Sun |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 11/29/2023 |
Decision Date | 01/16/2024 |
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
|