Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K924033 |
Device Name |
ALTEX MODEL UST-3000E |
Applicant |
OPTRO-MECHANICS (USA) CORP. |
ONE BLUE HILL PLAZA |
PEARL RIVER,
NY
10965
|
|
Applicant Contact |
SAL A CORTORILLO |
Correspondent |
OPTRO-MECHANICS (USA) CORP. |
ONE BLUE HILL PLAZA |
PEARL RIVER,
NY
10965
|
|
Correspondent Contact |
SAL A CORTORILLO |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 08/11/1992 |
Decision Date | 11/05/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|