The following data is part of a premarket notification filed by Fibra Sonics, Inc. with the FDA for Fibra Sonics Ultrasonic Lithotriptor Lithosonic, Model Ls-2000.
| Device ID | K993046 |
| 510k Number | K993046 |
| Device Name: | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 |
| Classification | Lithotriptor, Ultrasonic |
| 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 | FEO |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-10 |
| Decision Date | 1999-11-22 |