Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K991852 |
Device Name |
OCUSYSTEM ART ADVANTAGE, MODEL 995 |
Applicant |
SURGICAL DESIGN CORP. |
1050 CONNECTICUT AVENUE, NW |
WASHINGTON,
DC
20036 -5339
|
|
Applicant Contact |
WAYNE H MATELSKI |
Correspondent |
SURGICAL DESIGN CORP. |
1050 CONNECTICUT AVENUE, NW |
WASHINGTON,
DC
20036 -5339
|
|
Correspondent Contact |
WAYNE H MATELSKI |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 06/01/1999 |
Decision Date | 07/07/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|