Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K120377 |
Device Name |
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A |
Applicant |
J. MORITA USA, INC. |
1425 K STREET NW |
SUITE 1100 |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
KEITH A BARRITT |
Correspondent |
J. MORITA USA, INC. |
1425 K STREET NW |
SUITE 1100 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
KEITH A BARRITT |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/06/2012 |
Decision Date | 07/25/2012 |
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
|