VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab E1554 Reduced Eschar Electrode.

Pre-market Notification Details

Device IDK905529
510k NumberK905529
Device Name:VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
ContactPeggy Walline
CorrespondentPeggy Walline
VALLEYLAB, INC. 5920 LONGBOW DR. Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-10
Decision Date1991-02-21

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