Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K191933 |
Device Name |
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal |
Applicant |
Johnson & Johnson Surgical Vision, Inc. |
1700 East Saint Andrew Place |
Santa Ana,
CA
92705
|
|
Applicant Contact |
Larry Boucher |
Correspondent |
Johnson & Johnson Surgical Vision, Inc. |
1700 East Saint Andrew Place |
Santa Ana,
CA
92705
|
|
Correspondent Contact |
Larry Boucher |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/19/2019 |
Decision Date | 08/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|