OLYMPUS WORKING ELEMENT FOR PROBES

Resectoscope, Working Element

OLYMPUS WINTER & IBE GMBH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Olympus Working Element For Probes.

Pre-market Notification Details

Device IDK992141
510k NumberK992141
Device Name:OLYMPUS WORKING ELEMENT FOR PROBES
ClassificationResectoscope, Working Element
Applicant OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeFDC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-24
Decision Date1999-09-29
Summary:summary

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