ENDOSCOPE REPROCESSOR OER-PRO

Accessories, Cleaning, For Endoscope

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Endoscope Reprocessor Oer-pro.

Pre-market Notification Details

Device IDK093106
510k NumberK093106
Device Name:ENDOSCOPE REPROCESSOR OER-PRO
ClassificationAccessories, Cleaning, For Endoscope
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
Product CodeFEB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-01
Decision Date2010-02-12
Summary:summary

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