K130174 Trade / Americas Inc. / Electronic / Wildcat Medical Inc. / Ossur Americas Inc. / Predicate K061125 (Ossur Americas) Subject Device Americas Inc. / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / /
IndustryTerm
subject device / Internet address http /
MedicalCondition
chronic venous insufficiency / arterial and diabetic leg ulcers / venous stasis ulcers / pain / stasis dermatitis / Deep Vein Thrombosis / /
Organization
Device Evaluation Center / Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / office of Surveillance / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Division of Cardiovascular Devices / /
Person
Ubaldo Anaya / Mark Job / Brain D. Zuckerman / / /
Position
Director / Manager Device name and classification / Quality Assurance Manager / Manager 27051 Towne Center Drive Foothill Ranch / /
Section VIII VIII.A 510(k) Summary MAY[removed]k) Number K130174