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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: AMICUS Exchange Kit; AMICUS Separator System
Classification Name: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
Product Code: LKN
Device Class: U
Registered Establishment Name: FENWAL INTERNATIONAL, INC.
Registered Establishment Number: 9612051
Owner/Operator: Fenwal, Inc.
Owner/Operator Number: 9098803
Establishment Operations: Manufacturer
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