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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: CryoLife O'Brien Bioprosthesis
Classification Name: REPLACEMENT HEART-VALVE
Product Code: DYE
Device Class: 3
Regulation Number: 870.3925
Medical Specialty: Cardiovascular
Registered Establishment Name: CryoLife
Registered Establishment Number: 1063481
Owner/Operator: CryoLife
Owner/Operator Number: 9003683
Establishment Operations: U.S. Manufacturer of Export Only Devices
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