Device Classification Name |
Staple, Implantable
|
510(k) Number |
K161757 |
Device Name |
Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads |
Applicant |
VICTOR MEDICAL INSTRUMENTS CO.,LTD. |
NO.21, HUAFENG RD, QISHUYAN DISTRICT |
Changzhou,
CN
213018
|
|
Applicant Contact |
Yunhuo Chen |
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 | 06/27/2016 |
Decision Date | 12/05/2016 |
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
|
|
|