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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Essure; Essure System for Permanent Birth Control
Classification Name: INSERT, TUBAL OCCLUSION
Product Code: HHS
Device Class: 3
Regulation Number: 884.5380
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: CONCEPTUS, INC.
Registered Establishment Number: 2951250
Owner/Operator: CONCEPTUS, INC.
Owner/Operator Number: 9010233
Establishment Operations: Manufacturer; Repackager/Relabeler
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