AUDIANT BONE CONDUCTOR MANUFACTURED BY MEDTRONIC XOMED, INC.

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Request for Information Form	Contact Information
Company Name	MEDTRONIC XOMED, INC.
Address	6743 SOUTHPOINT DR. NORTH
City, State, Zip	JACKSONVILLE, FL 32216
Country	US
FDA Owner/Operator Phone	763-514-4000
FDA Medical Specialty Code	EN - Ear, Nose, Throat
FDA Product Code	LXB
FDA Classification Name	Hearing aid, bone conduction
FDA Device Classification Code	Standards
FDA Regulation Number	874.3300
FDA Common Generic Name	AUDIANT BONE CONDUCTOR
FDA Proprietary Device Name	AUDIANT BONE CONDUCTOR
FDA Owner / Operator Number	2112641
FDA Owner / Operator Name	MEDTRONIC INC.
FDA Establishment Registration Number	1045254
FDA Registered Establishment Name	MEDTRONIC XOMED, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	04-25-95
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	BHM-TECH PRODUKTIONSGESELLSCHAFT MBH 242 GRAFENSHACHEN GRAFENSHACHEN, 7423 AU 43-335-92007820 / 423-928-9060	BONE VIBRATOR FOR HEARING AID	BONE VIBRATOR FOR HEARING AID
2	COCHLEAR BONE ANCHORED SYSTEMS AB MOLNDALSVAGEN, 91 GOTEBORG, SE-412 21 SW 61-2-9428 6555 / 303-200-5435	MULTIPLE	VARIOUS MODELS OF BONE-ANCHORED HEARING AIDS
3	EAR TECHNOLOGY CORP. 604 N. ROAN ST., STE. 1 JOHNSON CITY, TN 37601 US 423-928-9060 / 423-928-9060	TRANSEAR	BONE CONDUCTION HEARING AID
4	ELOS MEDICAL AB BACKEDALSVAGEN/BOX45 TIMMERSDALA, SE540 16 SW 46-511-440600 / 46-511-440641	BAHA CORDELLE II SYSTEM/BAHA DIVINO SYSTEM	BONE ANCHORED HEARING AID
5	HEARING AIDS TODAY, INC. 134-B POWERS FERRY RD. MARIETTA, GA 30067 US 770-973-8750 / 770-973-8750	HEARING-AID, BONE-CONDUCTION	HEARING-AID, BONE-CONDUCTION
6	STARKEY LABORATORIES, INC. 6600-6700 WASHINGTON AVE.SOUTH EDEN PRAIRIE, MN 55344 US 952-941-6401 / 952-947-4734	FIDELITY MODEL F228 AND F229, VIENNATONE MODEL AN	BONE CONDUCTION EYEGLASS HEARING AIDS
7	WORDCOMP INTL. CORP. 18018 SOUTH WESTERN AVE. GARDENA, CA 90248 US 310-515-0106 / 310-515-0106	SECOND EAR, HEARING AID	BONE CONDUCTION HEARING AID