The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Alliger Ultrasonic Surgical System Model Auss-4.
Device ID | K000927 |
510k Number | K000927 |
Device Name: | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 |
Classification | Instrument, Ultrasonic Surgical |
Applicant | MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
Contact | Albert F Clancy Jr. |
Correspondent | Albert F Clancy Jr. 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 | 2000-03-22 |
Decision Date | 2000-10-10 |