AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017

Endoscopic Video Imaging System/component, Gastroenterology-urology

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Autoclavable Camer Head Model Otv-y0017.

Pre-market Notification Details

Device IDK102059
510k NumberK102059
Device Name:AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWY P.O. BOX 610 Center Valley,  PA  18034 -0610
ContactStacy Abbatiello Kluesner
CorrespondentStacy Abbatiello Kluesner
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWY P.O. BOX 610 Center Valley,  PA  18034 -0610
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-22
Decision Date2010-10-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170336669 K102059 000
04953170310799 K102059 000
04953170310782 K102059 000

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