Device Classification Name |
lens, contact, polymethylmethacrylate, diagnostic
|
510(k) Number |
K940107 |
Device Name |
VIRECTOMY LENS |
Applicant |
VISIONARY TECHNOLOGIES OF MIAMI, INC. |
8306 MILLS DRIVE, SUITE 147 |
MIAMI,
FL
33183
|
|
Applicant Contact |
THOMAS MESTRITS |
Correspondent |
VISIONARY TECHNOLOGIES OF MIAMI, INC. |
8306 MILLS DRIVE, SUITE 147 |
MIAMI,
FL
33183
|
|
Correspondent Contact |
THOMAS MESTRITS |
Regulation Number | 886.1385
|
Classification Product Code |
|
Date Received | 01/10/1994 |
Decision Date | 09/06/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|