Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K122202 |
Device Name |
ELLEX 2RT |
Applicant |
Ellex Medical Pty. Ltd. |
82 GILBERT ST. |
ADELAIDE, SOUTH AUSTRALIA,
AU
5000
|
|
Applicant Contact |
KEVIN HOWARD |
Correspondent |
Ellex Medical Pty. Ltd. |
82 GILBERT ST. |
ADELAIDE, SOUTH AUSTRALIA,
AU
5000
|
|
Correspondent Contact |
KEVIN HOWARD |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 07/25/2012 |
Decision Date | 07/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|