CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Instrument, Ultrasonic Surgical

INTEGRA RADIONICS, INC.

The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Cusa Shear Tip, An Accessory Of The Cusa Excel Ultrasonic Surgical Aspirator System.

Pre-market Notification Details

Device IDK090864
510k NumberK090864
Device Name:CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
ClassificationInstrument, Ultrasonic Surgical
Applicant INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington,  MA  01803
ContactKevin J O'connell
CorrespondentKevin J O'connell
INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington,  MA  01803
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-30
Decision Date2009-05-08
Summary:summary

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