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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Freedom SOLO Stentless Heart Valve (sizes 21 mm, 23 mm, 25 mm, and 27 mm); SOLO Smart Stentless Heart Valve (sizes 21 mm, 23 mm, 25 mm, and 27 mm)
Classification Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
Product Code: LWR
Device Class: 3
Registered Establishment Name: Sorin Group Canada Inc.
Registered Establishment Number: 3004478276
Owner/Operator: Sorin Group Canada Inc.
Owner/Operator Number: 10021830
Establishment Operations: Manufacturer; Repackager/Relabeler
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