The following data is part of a premarket notification filed by Phakosystems, Inc. with the FDA for Phakosystems Model 1000/omni Packs Irrigation/aspiration.
| Device ID | K830871 |
| 510k Number | K830871 |
| Device Name: | PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION |
| Classification | Clip, Iris Retractor |
| Applicant | PHAKOSYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOC |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-18 |
| Decision Date | 1983-06-02 |