Device Classification Name |
staple, implantable
|
510(k) Number |
K173270 |
Device Name |
Tri-Staple 2.0 Reinforced Reload |
Applicant |
Covidien |
60 Middletown Ave. |
North Haven,
CT
06473
|
|
Applicant Contact |
Rebecca Magnanimo |
Correspondent |
Covidien |
60 Middletown Ave. |
North Haven,
CT
06473
|
|
Correspondent Contact |
Rebecca Magnanimo |
Regulation Number | 878.4750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/12/2017 |
Decision Date | 02/20/2018 |
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
|
Recalls |
CDRH Recalls
|