The following data is part of a premarket notification filed by Fibra Sonics, Inc. with the FDA for Phaco Fragmentor Gt-1.
| Device ID | K834453 |
| 510k Number | K834453 |
| Device Name: | PHACO FRAGMENTOR GT-1 |
| Classification | Unit, Phacofragmentation |
| Applicant | FIBRA SONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-19 |
| Decision Date | 1984-03-16 |