HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH

Laparoscope, Gynecologic (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 Hd Endoeye Laparo-thoraco Videoscope Olympus Ltf Type Vh.

Pre-market Notification Details

Device IDK080948
510k NumberK080948
Device Name:HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeHET  
Subsequent Product CodeGCJ
Subsequent Product CodeNWB
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-03
Decision Date2008-09-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170310355 K080948 000
04953170287015 K080948 000

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