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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Omnilink Elite
Classification Name: STENT, ILIAC
Product Code: NIO
Device Class: 3
Registered Establishment Name: Abbott Vascular Netherlands
Registered Establishment Number: 3004091615
Premarket Submission Number: P110043
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Foreign Exporter
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