The following data is part of a premarket notification filed by Paradigm Medical Industries, Inc. with the FDA for Phacopak.
| Device ID | K974719 |
| 510k Number | K974719 |
| Device Name: | PHACOPAK |
| Classification | Unit, Phacofragmentation |
| Applicant | PARADIGM MEDICAL INDUSTRIES, INC. 1772 WEST 2300 SOUTH Salt Lake City, UT 84119 |
| Contact | Richard Dirkson |
| Correspondent | Richard Dirkson PARADIGM MEDICAL INDUSTRIES, INC. 1772 WEST 2300 SOUTH Salt Lake City, UT 84119 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-18 |
| Decision Date | 1998-01-20 |