Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K151306 |
Device Name |
Solea |
Applicant |
CONVERGENT DENTAL, INC |
2 VISION DR. |
NATICK,
MA
01760
|
|
Applicant Contact |
Mike Manor |
Correspondent |
EMERGO GROUP |
816 CONGRESS AVENUE, SUITE 1400 |
AUSTN,
TX
78701
|
|
Correspondent Contact |
Carrie Hetrick |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 05/18/2015 |
Decision Date | 09/23/2015 |
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
|