Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K210942 |
Device Name |
MicroFrance Monopolar and Bipolar Electrosurgical Instruments |
Applicant |
Integra MicroFrance |
Le Pavillon |
Saint Aubin Le Monial Allier,
FR
03160
|
|
Applicant Contact |
Malena Zammetti |
Correspondent |
Integra MicroFrance |
Le Pavillon |
Saint Aubin Le Monial Allier,
FR
03160
|
|
Correspondent Contact |
Malena Zammetti |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/30/2021 |
Decision Date | 05/14/2021 |
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
|