The following data is part of a premarket notification filed by Fibra Sonics, Inc. with the FDA for Fibra Sonics Ultrasonic Surgical Aspirator System, Model 1000 Console Model.
| Device ID | K983199 |
| 510k Number | K983199 |
| Device Name: | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL |
| Classification | Instrument, Ultrasonic Surgical |
| 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 | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-14 |
| Decision Date | 1998-12-14 |