Device Classification Name |
vitrectomy, instrument cutter
|
510(k) Number |
K081681 |
Device Name |
VITRECTOMY CUTTER AND ACCESSORIES |
Applicant |
ADVANCED MEDICAL OPTICS, INC. |
1700 E. ST. ANDREW PLACE |
P.O. BOX 25162 |
SANTA ANA,
CA
92705 -4933
|
|
Applicant Contact |
Evelyn De La Vega |
Correspondent |
ADVANCED MEDICAL OPTICS, INC. |
1700 E. ST. ANDREW PLACE |
P.O. BOX 25162 |
SANTA ANA,
CA
92705 -4933
|
|
Correspondent Contact |
Evelyn De La Vega |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 06/17/2008 |
Decision Date | 10/08/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|