Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K151783 |
Device Name |
COMPACT INTUITIV Multiple-Use Pack |
Applicant |
Abbott Medical Optics Inc. |
1700 East St. Andrew Place |
Santa Ana,
CA
92705
|
|
Applicant Contact |
Priya Viswanathan |
Correspondent |
Abbott Medical Optics Inc. |
1700 East St. Andrew Place |
Santa Ana,
CA
92705
|
|
Correspondent Contact |
Priya Viswanathan |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/01/2015 |
Decision Date | 09/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|