Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K212678 |
Device Name |
Viveve System, Viveve 2.0 System |
Applicant |
Viveve Medical, Inc. |
345 Inverness Drive South, Building B, Suite 250 |
Englewood,
CO
80109
|
|
Applicant Contact |
Kevin Robison |
Correspondent |
Viveve Medical, Inc. |
345 Inverness Drive South, Building B, Suite 250 |
Englewood,
CO
80109
|
|
Correspondent Contact |
Kevin Robison |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/24/2021 |
Decision Date | 09/14/2021 |
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
|
|
|