The following data is part of a premarket notification filed by Raico Llc with the FDA for Phacoemulsification Needle (tip) And Irrigation Sleeve.
| Device ID | K192418 |
| 510k Number | K192418 |
| Device Name: | Phacoemulsification Needle (Tip) And Irrigation Sleeve |
| Classification | Unit, Phacofragmentation |
| Applicant | Raico LLC 26 Plaza Dr Westmont, IL 60559 |
| Contact | Ravi Nallakrishnan |
| Correspondent | Ravi Nallakrishnan Raico LLC 26 Plaza Dr Westmont, IL 60559 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-05-27 |