ESSURE TM PERMANENT BIRTH CONTROL SYSTEM MANUFACTURED BY ACCELLENT INC.

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Request for Information Form	Contact Information
Company Name	ACCELLENT INC.
Address	1526-6 CALLE HERTZ
City, State, Zip	JUAREZ, CHIHUAHUA,
Country	MX
FDA Owner/Operator Phone	866-899-1392
FDA Medical Specialty Code	OB - Obstetrics/Gynecology
FDA Product Code	KNH
FDA Classification Name	DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	884.5380
FDA Common Generic Name	FEMALE STERILIZATION
FDA Proprietary Device Name	ESSURE TM PERMANENT BIRTH CONTROL SYSTEM
FDA Owner / Operator Number	9048369
FDA Owner / Operator Name	ACCELLENT INC.
FDA Establishment Registration Number	9680001
FDA Registered Establishment Name	ACCELLENT INC.
FDA Operation Code(s)	ME - Contract Manufacturer MM - Manufacturer
FDA Listing Date	09-30-03
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ACCELLENT EL PASO 31-C BUTTERFIELD TRAIL EL PASO, TX 79906 US 866-899-1392 / 915-782-1944	ESSURE TM PERMANENT BIRTH CONTROL SYSTEM	FEMALE STERILIZATION
2	CONCEPTUS, INC. 331 EAST EVELYN AVENUE MOUNTAIN VIEW, CA 94041 US 650-962-4000 / 650-962-4170	ESSURE PERMANENT BIRTH CONTROL SYSTEM	FEMALE STERILIZATION
3	FEMCARE LTD. UNIT 2A, MILLENNIUM WAY EAST PHEONIX CENTRE NOTTINGHAM, NG8 6AR UK 44-115-9767160 / 44-115-9767160	FILSHIE CLIP (MARK VI) SYSTEM	TUBAL OCCLUSION
4	GYRUS ACMI, INC. 6765 WEDGWOOD RD. MAPLE GROVE, MN 55311 US 011-44-189219750 / 508-804-2739	FALOPE-RING BAND AND ACCESSORIES	DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
5	WESLEY COE (CAMBRIDGE) LTD GAS LANE ELY, CAMBS, CB7 4GH UK 44-135-3667914 / 44-135-3667914	FILSHIE CLIP	DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE