ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ

Electrosurgical, Cutting & Coagulation & Accessories

OLYMPUS WINTER & IBE GMBH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Esg-400 Model Wb95051n, Footswitch Double Pedal Model Wb50402w, Footswitch Single Pedal Model Wb50403w, P-cord Model Maj.

Pre-market Notification Details

Device IDK103032
510k NumberK103032
Device Name:ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
ContactStacy Abbatiello Kluesner
CorrespondentStacy Abbatiello Kluesner
OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-12
Decision Date2011-01-14
Summary:summary

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