Device Classification Name |
staple, implantable
|
510(k) Number |
K202864 |
Device Name |
Tri-Staple 2.0 Reloads |
Applicant |
Covidien |
60 Middletown Avenue |
North Haven,
CT
06473
|
|
Applicant Contact |
Carolina Cabezas |
Correspondent |
Covidien |
60 Middletown Avenue |
North Haven,
CT
06473
|
|
Correspondent Contact |
Carolina Cabezas |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 09/28/2020 |
Decision Date | 10/28/2020 |
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
|
|
|