Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K091915 |
Device Name |
FLUID ISOLATION DEVICE |
Applicant |
LENSTEC, INC. |
1765 COMMERCE AVE N |
ST. PETERSBURG,
FL
33716
|
|
Applicant Contact |
JIMMY CHACKO |
Correspondent |
LENSTEC, INC. |
1765 COMMERCE AVE N |
ST. PETERSBURG,
FL
33716
|
|
Correspondent Contact |
JIMMY CHACKO |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 06/30/2009 |
Decision Date | 10/27/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|