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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: GDC-10; GDC-18 Ultrasoft
Classification Name: DEVICE, NEUROVASCULAR EMBOLIZATION
Product Code: HCG
Device Class: 2
Regulation Number: 882.5950
Medical Specialty: Neurology
Registered Establishment Name: Boston Scientific Limited
Registered Establishment Number: 9616684
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Contract Manufacturer; Manufacturer
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