| Device Classification Name |
powered laser surgical instrument
|
|---|
| 510(K) Number |
K120377 |
|---|
| Model |
MEY-1-A
|
| 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
|
|
| Contact |
keith a barritt |
| Regulation Number | 878.4810
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/07/2012 |
|---|
| Decision Date | 07/25/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
General & Plastic Surgery
|
|---|
| Review Advisory Committee |
General & Plastic Surgery
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
