The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Modification To Alliger Ultrasonic Surgical System, Model Auss-4.
Device ID | K982841 |
510k Number | K982841 |
Device Name: | MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 |
Classification | Instrument, Ultrasonic Surgical |
Applicant | MISONIX, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
Contact | Susan D Goldstein-falk |
Correspondent | Susan D Goldstein-falk MISONIX, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
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 | 1998-08-12 |
Decision Date | 1998-09-04 |
Summary: | summary |