Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K021566 |
Device Name |
INFINITI |
Applicant |
ALCON LABORATORIES, INC. |
6201 SOUTH FREEWAY |
FORT WORTH,
TX
76134 -2099
|
|
Applicant Contact |
MICHAEL BUENGER |
Correspondent |
ALCON LABORATORIES, INC. |
6201 SOUTH FREEWAY |
FORT WORTH,
TX
76134 -2099
|
|
Correspondent Contact |
MICHAEL BUENGER |
Regulation Number | 886.4670
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/13/2002 |
Decision Date | 07/02/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|