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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Gelseal Vascular Grafts
Classification Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
Product Code: MAL
Device Class: 2
Regulation Number: 870.3450
Medical Specialty: Cardiovascular
Registered Establishment Name: VASCUTEK LTD.
Registered Establishment Number: 9612515
Owner/Operator: Terumo Cardiovascular Systems Corp
Owner/Operator Number: 10039218
Establishment Operations: Manufacturer
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