Device Classification Name |
Staple, Implantable
|
510(k) Number |
K211458 |
Device Name |
Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers |
Applicant |
Ningbo VeryKind Medical Device Co., Ltd. |
#100 Jinghua Road, High-tech Industrial Development Zone |
Ningbo,
CN
315040
|
|
Applicant Contact |
Pengfei Hong |
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 |
|
Subsequent Product Code |
|
Date Received | 05/11/2021 |
Decision Date | 12/30/2021 |
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
|
|
|