Device Classification Name |
staple, implantable
|
510(k) Number |
K191070 |
Device Name |
Signia Small Diameter Reloads |
Applicant |
Covidien |
60 Middletown Avenue |
North Haven,
CT
06473
|
|
Applicant Contact |
Frank Gianelli |
Correspondent |
Covidien |
60 Middletown Avenue |
North Haven,
CT
06473
|
|
Correspondent Contact |
Frank Gianelli |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 04/22/2019 |
Decision Date | 09/04/2019 |
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
|