The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Auss-6 Ultrasonic Surgical Aspirator System.
| Device ID | K050776 |
| 510k Number | K050776 |
| Device Name: | AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| 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 | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-28 |
| Decision Date | 2005-06-06 |
| Summary: | summary |