The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems.
| Device ID | K041058 |
| 510k Number | K041058 |
| Device Name: | MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS |
| Classification | System, Suction, Lipoplasty |
| Applicant | MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
| Contact | Ronald R Manna |
| Correspondent | Ronald R Manna MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-23 |
| Decision Date | 2004-05-17 |
| Summary: | summary |