Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K981103 |
Device Name |
TURBOSONICS LIMITED REUSE ULTRASONIC TIP |
Applicant |
ALCON LABORATORIES |
6201 SOUTH FREEWAY |
R7-14 |
FORT WORTH,
TX
76134 -2099
|
|
Applicant Contact |
MARTIN A KAUFMAN |
Correspondent |
ALCON LABORATORIES |
6201 SOUTH FREEWAY |
R7-14 |
FORT WORTH,
TX
76134 -2099
|
|
Correspondent Contact |
MARTIN A KAUFMAN |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 03/26/1998 |
Decision Date | 06/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|