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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Ameda HygieniKit
Classification Name: PUMP, BREAST, POWERED
Product Code: HGX
Device Class: 2
Regulation Number: 884.5160
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: Ameda, Inc.
Registered Establishment Number: 3009974348
Premarket Submission Number: K011519
Owner/Operator: Ameda, Inc.
Owner/Operator Number: 10042362
Establishment Operations: Specification Developer