VALLEYLAB COATED ELECTRODES

Electrosurgical, Cutting & Coagulation & Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Coated Electrodes.

Pre-market Notification Details

Device IDK950188
510k NumberK950188
Device Name:VALLEYLAB COATED ELECTRODES
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder,  CO  80301
ContactJulie Ross
CorrespondentJulie Ross
VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-17
Decision Date1995-02-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521038554 K950188 000

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