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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: FC2 Female Condom
Classification Name: CONDOM, FEMALE, SINGLE-USE
Product Code: MBU
Device Class: 3
Regulation Number: 884.5330
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: The Female Health Company (M) Sdn Bhd
Registered Establishment Number: 3006633362
Owner/Operator: THE FEMALE HEALTH COMPANY
Owner/Operator Number: 9011102
Establishment Operations: Manufacturer
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