Device Classification Name |
Locator, Root Apex
|
510(k) Number |
K090925 |
Device Name |
MULTIPLE (APEX LOCATOR), MODEL RCM-7 |
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 |
Classification Product Code |
|
Date Received | 04/02/2009 |
Decision Date | 11/23/2009 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|