The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Sonatherm 600i Ultrasonic Lesion Generating System.
| Device ID | K070779 |
| 510k Number | K070779 |
| Device Name: | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM |
| Classification | System, Ablation, Ultrasound And Accessories |
| Applicant | MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
| Contact | Ronald Manna |
| Correspondent | Ronald Manna MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
| Product Code | NTB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-21 |
| Decision Date | 2008-07-09 |
| Summary: | summary |