The following data is part of a premarket notification filed by Johnson & Johnson Surgical Vision, Inc. with the FDA for Compact Intuitiv System, Compact Intuitiv Wireless Remote Control, Compact Intuitiv Four-button Foot Pedal, Compact Intuitiv Closed-toe Foot Pedal.
| Device ID | K191933 |
| 510k Number | K191933 |
| Device Name: | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal |
| Classification | Unit, Phacofragmentation |
| Applicant | Johnson & Johnson Surgical Vision, Inc. 1700 East Saint Andrew Place Santa Ana, CA 92705 |
| Contact | Larry Boucher |
| Correspondent | Larry Boucher Johnson & Johnson Surgical Vision, Inc. 1700 East Saint Andrew Place Santa Ana, CA 92705 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-19 |
| Decision Date | 2019-08-16 |