Device Classification Name |
Staple, Implantable
|
510(k) Number |
K172538 |
Device Name |
Disposable Linear Stapler, Disposable Linear Cutter |
Applicant |
Changzhou Kangdi Medical Stapler Co.,Ltd. |
No.16 Kunlun Road, XinBei Zone |
Changzhou City,
CN
213022
|
|
Applicant Contact |
Eve Zhou |
Correspondent |
IRC |
2091 Oak Drive |
Lake Havasu City,
AZ
86406
|
|
Correspondent Contact |
Charlie Mack |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 08/22/2017 |
Decision Date | 11/30/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|