ROLLER ELECTRODE

Electrode, Electrosurgical, Active, Urological

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Roller Electrode.

Pre-market Notification Details

Device IDK951863
510k NumberK951863
Device Name:ROLLER ELECTRODE
ClassificationElectrode, Electrosurgical, Active, Urological
Applicant OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success,  NY  11042 -1179
ContactBarry E Sands
CorrespondentBarry E Sands
OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success,  NY  11042 -1179
Product CodeFAS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-21
Decision Date1995-08-24

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