IMMUNO ADSORPTION SYSTEM MANUFACTURED BY FRESENIUS HEMOCARE NETHERLANDS B.V.

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Request for Information Form	Contact Information
Company Name	FRESENIUS HEMOCARE NETHERLANDS B.V.
Address	RUNDE ZZ 41
City, State, Zip	EMMER-COMPASCUUM,
Country	NL
FDA Owner/Operator Phone	49-617-26080
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	FLD
FDA Classification Name	APPARATUS, HEMOPERFUSION, SORBENT
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	876.5870
FDA Common Generic Name	MULTIPLE
FDA Proprietary Device Name	IMMUNO ADSORPTION SYSTEM
FDA Owner / Operator Number	9027285
FDA Owner / Operator Name	FRESENIUS KABI AG
FDA Establishment Registration Number	9610969
FDA Registered Establishment Name	FRESENIUS HEMOCARE NETHERLANDS B.V.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	08-23-05
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	AMERICAN HEALTH CARE SYSTEMS, INC. 3350 RIDGELAKE AVE., SUITE 255 METAIRIE, LA 70002 US 504-831-4867 / 504-831-4867	MULTIPLE	VARIOUS TYPES AND SIZES
2	FRESENIUS HEMOCARE 14787 NE 95TH ST. REDMOND, WA 98052 US 781-699-9000 / 781-402-9068	PROSORBA	PROTEIN A IMMUNOADSORPTION COLUMN
3	GAMBRO DIAYLZATOREN GMBH HOLGER - CRAFOORD - STRASSE 26 HECHINGEN, D-72379 GM / 303-231-4094	ADSORBA	ADSORBA
4	GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY LAKEWOOD, CO 80401 US / 303-542-5075	ADSORBA	SORBENT HEMOPERFUSION
5	NEXTRON MEDICAL TECHNOLOGIES, INC. 45 KULICK RD. FAIRFIELD, NJ 07004 US 800-633-7877 / 800-633-7877	HEMOSORBA	SORBENT HEMOPERFUSION SYSTEM