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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Onyx AVM; Onyx® Liquid Embolic System
Classification Name: AGENT, INJECTABLE, EMBOLIC
Product Code: MFE
Device Class: 3
Registered Establishment Name: Micro Therapeutics, Inc. dba ev3 Neurovascular
Registered Establishment Number: 2029214
Owner/Operator: ev3 Inc.
Owner/Operator Number: 9025796
Establishment Operations: Manufacturer; U.S. Manufacturer of Export Only Devices
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