Device Classification Name |
unit, x-ray, extraoral with timer
|
510(k) Number |
K122124 |
Device Name |
PORTABLE X-RAY SYSTEM |
Applicant |
OSSTEM IMPLANT CO.,LTD |
85 BEN FAIRLESS DR. |
FAIRLESS HILLS,
PA
19030
|
|
Applicant Contact |
PATRICK LIM |
Correspondent |
OSSTEM IMPLANT CO.,LTD |
85 BEN FAIRLESS DR. |
FAIRLESS HILLS,
PA
19030
|
|
Correspondent Contact |
PATRICK LIM |
Regulation Number | 872.1800
|
Classification Product Code |
|
Date Received | 07/18/2012 |
Decision Date | 05/16/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|