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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Falope Ring Band; Falope Ring Band Applicator Kits
Classification Name: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
Product Code: KNH
Device Class: 3
Regulation Number: 884.5380
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: GYRUS ACMI, INC.
Registered Establishment Number: 2183680
Owner/Operator: Olympus Medical Systems Corporation
Owner/Operator Number: 9067818
Establishment Operations: Manufacturer
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