The following data is part of a premarket notification filed by Edap Technomed, Inc. with the FDA for Sonolith Praktis, Endourology Table Praktis.
| Device ID | K003529 |
| 510k Number | K003529 |
| Device Name: | SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | EDAP TECHNOMED, INC. 100 PINNACLE WAY SUITE 100 Norcross, GA 30071 |
| Contact | Scott J Mindrebo |
| Correspondent | Scott J Mindrebo EDAP TECHNOMED, INC. 100 PINNACLE WAY SUITE 100 Norcross, GA 30071 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-16 |
| Decision Date | 2001-02-12 |