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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CardioWest TAH-t
Classification Name: ARTIFICIAL HEART
Product Code: LOZ
Device Class: 3
Registered Establishment Name: SYNCARDIA SYSTEMS, INC.
Registered Establishment Number: 3003761017
Owner/Operator: SYNCARDIA SYSTEMS, INC.
Owner/Operator Number: 9067898
Establishment Operations: Manufacturer
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