Device Classification Name |
staple, implantable
|
510(k) Number |
K181657 |
Device Name |
easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use |
Applicant |
Ezisurg Medical Co., Ltd. |
Rm. 103, Bldg.2, No.1690 Cailun Road |
China (Shanghai) Pilot Free Trade Zone |
Shanghai,
CN
201203
|
|
Applicant Contact |
Liang Xia |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O.BOX 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 06/22/2018 |
Decision Date | 02/01/2019 |
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
|
|
|