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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: FC 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: MAYER LABORATORIES
Registered Establishment Number: 2938651
Owner/Operator Number: 2938651
Establishment Operations: Repackager/Relabeler