NECLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS, NUCLEUS 24 COCHLEAR IMPLA MANUFACTURED BY COCHLEAR LTD.

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Request for Information Form	Contact Information
Company Name	COCHLEAR LTD.
Address	14 MARS ROAD
City, State, Zip	LANE COVE NSW,
Country	AS
FDA Owner/Operator Phone	61-2-9428 6555
FDA Medical Specialty Code	EN - Ear, Nose, Throat
FDA Product Code	MCM
FDA Classification Name	IMPLANT, COCHLEAR
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	IMPLANT, COCHLEAR, IMPLANT, AUDITORY BRAINSTEM
FDA Proprietary Device Name	NECLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS, NUCLEUS 24 COCHLEAR IMPLA
FDA Owner / Operator Number	9076254
FDA Owner / Operator Name	COCHLEAR LTD.
FDA Establishment Registration Number	3002806740
FDA Registered Establishment Name	COCHLEAR LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-15-06
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	ADVANCED BIONICS CORP. 12740 SAN FERNANDO RD. SYLMAR, CA 91342 US 508-652-5594 / 508-652-5594	CLARION CII BIONIC EAR, HIRESOLUTION BIONIC EAR SYSTEM	COCHLEAR IMPLANT
2	COCHLEAR AMERICAS 400 INVERNESS PKWY., SUITE 400 ENGLEWOOD, CO 80112 US 61-2-9428 6555 / 303-200-5435	IMPLANT, COCHLEAR	NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
3	MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH FUERSTENWEG 77A INNSBRUCK, TIROL, A-6020 AU 43-512-288889 600 / 43-512-288889 600	COMBI 40+ COCHLEAR IMPLANT SYSTEM	COCHLEAR IMPLANT