ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF

Instrument, Ultrasonic Surgical

MISONIX, INC.

The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Ultrasonic Surgical Aspirator System, Model Fs 1000 Rf.

Pre-market Notification Details

Device IDK062471
510k NumberK062471
Device Name:ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
ClassificationInstrument, Ultrasonic Surgical
Applicant MISONIX, INC. 1938 NEW HIGHWAY Farmingdale,  NY  11735
ContactRonald R Manna
CorrespondentRonald R Manna
MISONIX, INC. 1938 NEW HIGHWAY Farmingdale,  NY  11735
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-24
Decision Date2006-10-26
Summary:summary

NIH GUDID Devices

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