Device Classification Name |
Staple, Implantable
|
510(k) Number |
K121474 |
Device Name |
DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER |
Applicant |
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. |
77325 JOYCE WAY |
ECHO,
OR
97826
|
|
Applicant Contact |
CHARLES MACK |
Correspondent |
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. |
77325 JOYCE WAY |
ECHO,
OR
97826
|
|
Correspondent Contact |
CHARLES MACK |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 05/18/2012 |
Decision Date | 07/16/2012 |
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
|
|
|