Device Classification Name |
Locator, Root Apex
|
510(k) Number |
K101177 |
Device Name |
APEXNRG RIDER |
Applicant |
MEDICNRG LTD. |
291 HILLSIDE AVE. |
SOMERSET,
MA
02726
|
|
Applicant Contact |
George Hattub |
Correspondent |
MEDICNRG LTD. |
291 HILLSIDE AVE. |
SOMERSET,
MA
02726
|
|
Correspondent Contact |
George Hattub |
Classification Product Code |
|
Date Received | 04/27/2010 |
Decision Date | 10/08/2010 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|