ADSORBA MANUFACTURED BY GAMBRO RENAL PRODUCTS, INC.

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Request for Information Form	Contact Information
Company Name	GAMBRO RENAL PRODUCTS, INC.
Address	14143 DENVER WEST PARKWAY
City, State, Zip	LAKEWOOD, CO 80401
Country	US
FDA Owner/Operator Phone	--
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	SORBENT HEMOPERFUSION
FDA Proprietary Device Name	ADSORBA
FDA Owner / Operator Number	9038727
FDA Owner / Operator Name	GAMBRO
FDA Establishment Registration Number	2087532
FDA Registered Establishment Name	GAMBRO RENAL PRODUCTS, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	02-20-07
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	FRESENIUS HEMOCARE NETHERLANDS B.V. RUNDE ZZ 41 EMMER-COMPASCUUM, NL-7881 HM NL 49-617-26080 / 31-591-355745	IMMUNO ADSORPTION SYSTEM	MULTIPLE
4	GAMBRO DIAYLZATOREN GMBH HOLGER - CRAFOORD - STRASSE 26 HECHINGEN, D-72379 GM / 303-231-4094	ADSORBA	ADSORBA
5	NEXTRON MEDICAL TECHNOLOGIES, INC. 45 KULICK RD. FAIRFIELD, NJ 07004 US 800-633-7877 / 800-633-7877	HEMOSORBA	SORBENT HEMOPERFUSION SYSTEM