| Device Classification Name |
Locator, Root Apex
|
| 510(k) Number |
K890735 |
| Device Name |
COATED APEX PROBE |
| Applicant |
| Analytic Technology |
| 15233 Northeast 90th St. |
|
Redmond,
WA
98052
|
|
| Applicant Contact |
JOHAN MASRELIEZ |
| Correspondent |
| Analytic Technology |
| 15233 Northeast 90th St. |
|
Redmond,
WA
98052
|
|
| Correspondent Contact |
JOHAN MASRELIEZ |
| Classification Product Code |
|
| Date Received | 02/13/1989 |
| Decision Date | 04/19/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|