IMPLANT, COCHLEAR MANUFACTURED BY COCHLEAR AMERICAS

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This company has been viewed 10 times within the past 60 days.

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Request for Information Form	Contact Information
Company Name	COCHLEAR AMERICAS
Address	400 INVERNESS PKWY., SUITE 400
City, State, Zip	ENGLEWOOD, CO 80112
Country	US
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	NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA Proprietary Device Name	IMPLANT, COCHLEAR
FDA Owner / Operator Number	9076254
FDA Owner / Operator Name	COCHLEAR LTD.
FDA Establishment Registration Number	1721493
FDA Registered Establishment Name	COCHLEAR AMERICAS
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	09-04-92
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 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
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