Device Classification Name |
implant, eye valve
|
510(k) Number |
K030350 |
Device Name |
EXPRESS MINI GLAUCOMA SHUNT |
Applicant |
OPTONOL, LTD |
SURGICAL BUSINESS UNIT |
11460 JOHNS CREEK PARKWAY |
DULUTH,
GA
30097
|
|
Applicant Contact |
PENNY NORTHCUTT |
Correspondent |
OPTONOL, LTD |
SURGICAL BUSINESS UNIT |
11460 JOHNS CREEK PARKWAY |
DULUTH,
GA
30097
|
|
Correspondent Contact |
PENNY NORTHCUTT |
Regulation Number | 886.3920
|
Classification Product Code |
|
Date Received | 02/03/2003 |
Decision Date | 03/13/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|