Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K911808 |
Device Name |
GEMINI OPHTHALMIC SURGERY SYSTEM |
Applicant |
ALCON LABORATORIES |
6201 SOUTH FREEWAY |
R7-14 |
FORT WORTH,
TX
76134 -2099
|
|
Applicant Contact |
DAVID KRAPF |
Correspondent |
ALCON LABORATORIES |
6201 SOUTH FREEWAY |
R7-14 |
FORT WORTH,
TX
76134 -2099
|
|
Correspondent Contact |
DAVID KRAPF |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 04/23/1991 |
Decision Date | 06/25/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|