| Device Classification Name |
Activator, Ultraviolet, For Polymerization
|
| 510(k) Number |
K020057 |
| Device Name |
PALMLIGHT |
| Applicant |
| CAO Group, Inc. |
| 8685 S. 7th W. |
|
Sandy,
UT
84070
|
|
| Applicant Contact |
TRACY S BEST |
| Correspondent |
| CAO Group, Inc. |
| 8685 S. 7th W. |
|
Sandy,
UT
84070
|
|
| Correspondent Contact |
TRACY S BEST |
| Regulation Number | 872.6070 |
| Classification Product Code |
|
| Date Received | 01/08/2002 |
| Decision Date | 08/27/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|