Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K191601 |
Device Name |
Valleylab FT10 Electrosurgical Platform |
Applicant |
Covidien |
5920 Longbow Drive |
Boulder,
CO
80301
|
|
Applicant Contact |
Jennie van Diemen |
Correspondent |
Covidien |
5920 Longbow Drive |
Boulder,
CO
80301
|
|
Correspondent Contact |
Jennie van Diemen |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/17/2019 |
Decision Date | 07/12/2019 |
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
|
Recalls |
CDRH Recalls
|