MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Instrument, Ultrasonic Surgical

MISONIX, INC.

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

Pre-market Notification Details

Device IDK032690
510k NumberK032690
Device Name:MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
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 Received2003-09-02
Decision Date2003-12-09
Summary:summary

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