The following data is part of a premarket notification filed by Edap Technomed, Inc. with the FDA for Ablatherm Fusion.
| Device ID | K172285 |
| 510k Number | K172285 |
| Device Name: | Ablatherm Fusion |
| Classification | High Intensity Ultrasound System For Prostate Tissue Ablation |
| Applicant | EDAP TECHNOMED, INC. 5321 Industrial Oaks Blvd, Suite 110 Austin, TX 78735 |
| Contact | Hugo Embert |
| Correspondent | Hugo Embert EDAP TECHNOMED, INC. 5321 Industrial Oaks Blvd, Suite 110 Austin, TX 78735 |
| Product Code | PLP |
| CFR Regulation Number | 876.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-28 |
| Decision Date | 2017-10-03 |
| Summary: | summary |