MODEL E2517 AND MODEL E2503 POWER CONTROL PENCILS

Electrosurgical, Cutting & Coagulation & Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Model E2517 And Model E2503 Power Control Pencils.

Pre-market Notification Details

Device IDK861112
510k NumberK861112
Device Name:MODEL E2517 AND MODEL E2503 POWER CONTROL PENCILS
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 Received1986-03-25
Decision Date1986-05-20

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