AORTIC VALVE; PULMONIC VALVE MANUFACTURED BY REGENERATION TECHNOLOGIES, INC.

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Request for Information Form	Contact Information
Company Name	REGENERATION TECHNOLOGIES, INC.
Address	11621 RESEARCH CIR. P.O. BOX 2650
City, State, Zip	ALACHUA, FL 32616
Country	US
FDA Owner/Operator Phone	386-418-8888
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	LWR
FDA Classification Name	TISSUE, HEART-VALVE
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	AORTIC VALVE; PULMONIC VALVE
FDA Proprietary Device Name	AORTIC VALVE; PULMONIC VALVE
FDA Owner / Operator Number	9053392
FDA Owner / Operator Name	REGENERATION TECHNOLOGIES, INC.
FDA Establishment Registration Number	3002719998
FDA Registered Establishment Name	REGENERATION TECHNOLOGIES, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	07-07-04
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	3F THERAPEUTICS, INC. 20412 JAMES BAY CIRCLE LAKE FOREST, CA 92630 US 949-380-9333 / 949-380-9333 235	TISSUE, HEART-VALVE	TISSUE, HEART-VALVE
2	ALABAMA TISSUE CENTER, INC. 1900 UNIVERSITY BLVD. 855 TINSLEY HARRISON TOWER BIRMINGHAM, AL 35294 US 205-934-4314 / 205-934-4314	AORTIC HUMAN ALLOGRAFT HEART VALVE/PULMONARY HUMAN ALLOGRAFT HEART VALVE	HEART VALVE, TISSUE
3	EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US 949-250-2500 / 949-250-2698	TISSUE, HEART-VALVE	TISSUE, HEART-VALVE
4	GLYCAR SA PTY., LTD. 1 ALBERT RD., BOX 967 IRENE, 0062 SF / 914-779-8878	GLYCAR QUADRICUSP MITRAL BIOPROSTHESIS	STENTLESS, CHORDALLY SUPPORTED MITRAL BIOPROSTHESIS
5	ST JUDE MEDICAL RUA DA PAISAGEM 310B VILA DA SERRA, CEP 34.000-000 NOVA LIMA, MINAS GERAIS, BR 651-483-2000 / 651-415-7029	BIOCOR AND EPIC TISSUE VALVES	TISSUE HEART VALVES
6	ST. JUDE MEDICAL ONE LILLEHEI PLAZA ST. PAUL, MN 55117 US 651-483-2000 / 651-415-7029	TORONTO SPV VALVE	TISSUE VALVE, VARIOUS SIZES & ACCESSORIES
7	ST. JUDE MEDICAL 2550 BLVD. VANIER ST. HYACINTHE, QUEBEC, J2S6L7 CA 651-483-2000 / 651-415-7029	TORONTO SPV VALVE	TISSUE VALVE, VARIOUS SIZES & ACCESSORIES
8	THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG 1851 EAST DEERE AVE. SANTA ANA, CA 92705 US 763-514-4000 / 763-391-9030	MULTIPLE	VARIOUS MODELS AND SIZES OF PORCINE BIOPROSTHESES AND CONDUITS