Device Classification Name |
single use only blood lancet with an integral sharps injury prevention feature
|
510(k) Number |
K210745 |
Device Name |
Heel Incision Safety Lancet |
Applicant |
SteriLance Medical (Suzhou) Inc. |
No.168 PuTuoShan Road, New District |
Suzhou,
CN
215153
|
|
Applicant Contact |
Yuan Jie |
Correspondent |
Shenzhen Joyantech Consulting Co., Ltd. |
1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan |
District |
Shenzhen,
CN
518100
|
|
Correspondent Contact |
Joyce Yang |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 03/12/2021 |
Decision Date | 08/26/2021 |
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
|
|
|