The following data is part of a premarket notification filed by Medical Technical Products with the FDA for I/a-phaco System (irr./aspir./and Phaco./system).
| Device ID | K904612 |
| 510k Number | K904612 |
| Device Name: | I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) |
| Classification | Unit, Phacofragmentation |
| Applicant | MEDICAL TECHNICAL PRODUCTS 23042 ALCALDE, SUITE A Laguna Hills, CA 92653 |
| Contact | James Bakos |
| Correspondent | James Bakos MEDICAL TECHNICAL PRODUCTS 23042 ALCALDE, SUITE A Laguna Hills, CA 92653 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-11 |
| Decision Date | 1990-12-26 |