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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: ONE FLEX
Classification Name: CONDOM
Product Code: HIS
Device Class: 2
Regulation Number: 884.5300
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: GLOBAL PROTECTION CORP.
Registered Establishment Number: 1222115
Premarket Submission Number: K203536
Owner/Operator: Global Protection Corp.
Owner/Operator Number: 9008037
Establishment Operations: Repackager/Relabeler; Specification Developer
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