LAPARO-THORACO VIDEOSCOPE XLTF-VAW

Laparoscope, General & Plastic Surgery

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Laparo-thoraco Videoscope Xltf-vaw.

Pre-market Notification Details

Device IDK053382
510k NumberK053382
Device Name:LAPARO-THORACO VIDEOSCOPE XLTF-VAW
ClassificationLaparoscope, General & Plastic Surgery
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
ContactTracy Gulsen
CorrespondentTracy Gulsen
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-05
Decision Date2006-05-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170353222 K053382 000
04953170025570 K053382 000
04953170025563 K053382 000
04953170023118 K053382 000
04953170022746 K053382 000

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