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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Epic™ Max Valve (Aortic); Epic™ Plus Supra Valve (Aortic); Epic™ Plus Valve (Aortic); Epic™ Plus Valve (Mitral); Epic™ Supra Valve (Aortic); Epic™ Valve (Aortic); Epic™ Valve (Mitral)
Classification Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
Product Code: LWR
Device Class: 3
Registered Establishment Name: Abbott Medical
Registered Establishment Number: 3007113487
Premarket Submission Number: P040021
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
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