Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K081565 |
Device Name |
INTEGRE PRO, MODEL L2RY |
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 | 06/04/2008 |
Decision Date | 07/02/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|