Device Classification Name |
Staple, Implantable
|
510(k) Number |
K201639 |
Device Name |
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads |
Applicant |
Beijing Biosis Healing Biological Technology Co., Ltd. |
Valley No.1 Bio-medicine Industry Park, Daxing District |
Beijing,
CN
102600
|
|
Applicant Contact |
Ting Jiang |
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 | 06/16/2020 |
Decision Date | 05/27/2021 |
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
|
|
|