The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Alliger Ultrasonic Surgical System Model Auss-5.
| Device ID | K012028 |
| 510k Number | K012028 |
| Device Name: | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
| Contact | Albert F Clancy |
| Correspondent | Albert F Clancy MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-28 |
| Decision Date | 2001-07-27 |
| Summary: | summary |