The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Nexus Ultrasonic Surgical Aspirator System.
Device ID | K190160 |
510k Number | K190160 |
Device Name: | NeXus Ultrasonic Surgical Aspirator System |
Classification | Instrument, Ultrasonic Surgical |
Applicant | Misonix, Inc. 1938 New Highway Farmingdale, NY 11735 |
Contact | John Salerno |
Correspondent | John Salerno 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 | 2019-01-30 |
Decision Date | 2019-05-30 |