UPD-Y0003

Colonoscope And Accessories, Flexible/rigid

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Upd-y0003.

Pre-market Notification Details

Device IDK103312
510k NumberK103312
Device Name:UPD-Y0003
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
ContactStacy Kluesner
CorrespondentStacy Kluesner
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-10
Decision Date2011-05-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170313202 K103312 000
04953170305764 K103312 000
04953170305740 K103312 000
04953170305726 K103312 000
04953170305719 K103312 000
04953170305702 K103312 000
04953170305696 K103312 000
04953170305689 K103312 000
04953170305672 K103312 000
04953170305665 K103312 000
04953170026010 K103312 000
04953170305771 K103312 000
04953170305788 K103312 000
04953170305887 K103312 000
04953170305870 K103312 000
04953170305863 K103312 000
04953170305856 K103312 000
04953170305849 K103312 000
04953170305832 K103312 000
04953170305825 K103312 000
04953170305818 K103312 000
04953170305801 K103312 000
04953170305795 K103312 000
04953170026003 K103312 000

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