COMBI 40+ COCHLEAR IMPLANT SYSTEM MANUFACTURED BY MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

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Request for Information Form	Contact Information
Company Name	MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
Address	FUERSTENWEG 77A
City, State, Zip	INNSBRUCK, TIROL,
Country	AU
FDA Owner/Operator Phone	43-512-288889 600
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	COCHLEAR IMPLANT
FDA Proprietary Device Name	COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Owner / Operator Number	9042031
FDA Owner / Operator Name	VIBRANT MED-EL HEARING TECHNOLOGY GMBH
FDA Establishment Registration Number	9710014
FDA Registered Establishment Name	MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	08-16-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	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	COCHLEAR LTD. 14 MARS ROAD LANE COVE NSW, 2066 AS 61-2-9428 6555 / 303-524-6792	NECLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS, NUCLEUS 24 COCHLEAR IMPLA	IMPLANT, COCHLEAR, IMPLANT, AUDITORY BRAINSTEM