CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.

Device, Neurosurgical Fragmentation And Aspiration

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa System 200c,t & M Ultrasonic Surgical Aspira..

Pre-market Notification Details

Device IDK884412
510k NumberK884412
Device Name:CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.
ClassificationDevice, Neurosurgical Fragmentation And Aspiration
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
ContactPeggy Walline
CorrespondentPeggy Walline
VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
Product CodeLBK  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-20
Decision Date1988-12-02

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