The following data is part of a premarket notification filed by Fibra Sonics, Inc. with the FDA for Fibra-sonics Phaco Iii Or Iiip Fragmentation System.
| Device ID | K984143 |
| 510k Number | K984143 |
| Device Name: | FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | FIBRA SONICS, INC. 5312 N. ELSTON AVE. Chicago, IL 60630 |
| Contact | Robert Brohm |
| Correspondent | Robert Brohm FIBRA SONICS, INC. 5312 N. ELSTON AVE. Chicago, IL 60630 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-18 |
| Decision Date | 1999-02-16 |