SMALL INTESTINAL VIDEOSCOPE SYSTEM

Tubes, Gastrointestinal (and Accessories)

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Small Intestinal Videoscope System.

Pre-market Notification Details

Device IDK051551
510k NumberK051551
Device Name:SMALL INTESTINAL VIDEOSCOPE SYSTEM
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactLaura Storms-tyler
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-06-13
Decision Date2005-06-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170060434 K051551 000
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