Device Classification Name |
implant, eye valve
|
510(k) Number |
K905129 |
Device Name |
BAERVELDT GLAUCOMA IMPLANT |
Applicant |
WRIGHT MEDICAL CORP. |
P.O. BOX 800 |
PEAPACK,
NJ
07977
|
|
Applicant Contact |
RONALD J GARUTTI |
Correspondent |
WRIGHT MEDICAL CORP. |
P.O. BOX 800 |
PEAPACK,
NJ
07977
|
|
Correspondent Contact |
RONALD J GARUTTI |
Regulation Number | 886.3920
|
Classification Product Code |
|
Date Received | 11/14/1990 |
Decision Date | 02/11/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|