CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR

Instrument, Ultrasonic Surgical

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa(r) System 200c/200t/200m/200h Ultra Aspirator.

Pre-market Notification Details

Device IDK910696
510k NumberK910696
Device Name:CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR
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 Received1991-02-19
Decision Date1991-06-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.