The following data is part of a premarket notification filed by M. Imonti And Associates Inc., with the FDA for Phacofragmentor Tip.
| Device ID | K933627 |
| 510k Number | K933627 |
| Device Name: | PHACOFRAGMENTOR TIP |
| Classification | Unit, Phacofragmentation |
| Applicant | M. IMONTI AND ASSOCIATES INC., 25707 COMPASS WAY San Juan Capistrano, CA 92675 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1994-01-25 |