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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Essure
Classification Name: INSERT, TUBAL OCCLUSION
Product Code: HHS
Device Class: 3
Regulation Number: 884.5380
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: Venusa de Mexico S.A. de C. V. a Lake Region Medical Company
Registered Establishment Number: 9680001
Owner/Operator: Accellent Inc d/b/a Lake Region Medical
Owner/Operator Number: 9048369
Establishment Operations: Contract Manufacturer