The following data is part of a premarket notification filed by Fibra Sonics, Inc. with the FDA for Ultrasonic Lithotriptor 300a.
| Device ID | K842024 |
| 510k Number | K842024 |
| Device Name: | ULTRASONIC LITHOTRIPTOR 300A |
| Classification | Lithotriptor, Ultrasonic |
| Applicant | FIBRA SONICS, INC. 5312 N. ELSTON AVE. Chicago, IL 60630 |
| Contact | Kirchschlager |
| Correspondent | Kirchschlager 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 | 1984-05-18 |
| Decision Date | 1984-12-11 |