ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES

Electrode, Electrosurgical, Active, Urological

OLYMPUS WINTER & IBE GMBH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Electrosugrical Resection And Vaporization Electrode Series.

Pre-market Notification Details

Device IDK120418
510k NumberK120418
Device Name:ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
ClassificationElectrode, Electrosurgical, Active, Urological
Applicant OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY PO BOX 610 Center Valley,  PA  18034 -0610
ContactSheri Musgnung
CorrespondentSheri Musgnung
OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeFAS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-10
Decision Date2012-06-20
Summary:summary

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