The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Phaco 20/20 System I.
| Device ID | K915457 |
| 510k Number | K915457 |
| Device Name: | PHACO 20/20 SYSTEM I |
| Classification | Unit, Phacofragmentation |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. 45 MALL DR. Commack, NY 11725 |
| Contact | Joseph Spinosa |
| Correspondent | Joseph Spinosa INNOVATIVE MEDICAL SYSTEMS, INC. 45 MALL DR. Commack, NY 11725 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-05 |
| Decision Date | 1992-02-24 |