CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.

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/t Ultrasonic Aspirator & Access..

Pre-market Notification Details

Device IDK931902
510k NumberK931902
Device Name:CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.
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 Received1993-04-19
Decision Date1994-09-16

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