CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY

Instrument, Ultrasonic Surgical

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa System 200c Ultrasonic Aspirator/cusa System 200t Ultrasonic Aspirator/cusa Lap Accessory.

Pre-market Notification Details

Device IDK964601
510k NumberK964601
Device Name:CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
ClassificationInstrument, Ultrasonic Surgical
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
ContactPeggy Walline
CorrespondentPeggy Walline
VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-18
Decision Date1997-01-16
Summary:summary

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