CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS

Instrument, Ultrasonic Surgical

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa(r) Syst 200ct/200t Ultra Aspir Lap/cem Access.

Pre-market Notification Details

Device IDK934628
510k NumberK934628
Device Name:CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM 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 Received1993-09-15
Decision Date1995-07-11

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