The U.S. Food and Drug Administration (FDA) must approve all medical devices before they can be marketed. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).
DEVICE: GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H GAMBRO RENAL PRODUCTS 510(k) NO: K051520 (TRADITIONAL) ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094 10810 WEST COLLINS AVE. SE DECISION MADE: 09-DEC-05 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION NXSTAGE MEDICAL, INC. 510(k) NO: K053286 (SPECIAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 22-DEC-05 LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERIM PERACETIC ACID CHEMICAL INDICATOR SERIM RESEARCH CORP. 510(k) NO: K052388 (TRADITIONAL) ATTN: PATRICIA A RUPCHOCK PHONE NO : 574-264-3440 23565 REEDY DR. SE DECISION MADE: 01-DEC-05 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B. BRAUN MODIFIED BICARBONATE DIALYSATE B. BRAUN MEDICAL, INC. 510(k) NO: K052393(SPECIAL) ATTN: CHRISTINE FORD PHONE NO : 610-596-2367 901 MARCON BLVD. SE DECISION MADE: 09-NOV-05 ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMO GAMBRO RENAL PRODUCTS 510(k) NO: K052253(SPECIAL) ATTN: FEI LAW PHONE NO : 386-274-2811 1845 MASON AVE. SE DECISION MADE: 02-NOV-05 DAYTONA BEACH, FL 32117-5102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQR BETTER WATER, INC. 510(k) NO: K051620(ABBREVIATED) ATTN: MICHAEL CLINE PHONE NO : 615-355-6063 698 SWAN DR. SE DECISION MADE: 18-NOV-05 SMYRNA, TN 37167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) DIALYSIS SOLUTIONS, INC. 510(k) NO: K050827(TRADITIONAL) ATTN: MARCY MACDONALD PHONE NO : 847-279-7740 616 HEATHROW DRIVE SE DECISION MADE: 22-AUG-05 LINCOLNSHIRE, IL 60069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET JMS NORTH AMERICA CORP. 510(k) NO: K051814(SPECIAL) ATTN: CHONG SWEE CHEAU PHONE NO : 510-888-9093 22320 FOOTHILL BLVD., SE DECISION MADE: 04-AUG-05 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA HAYWARD, CA 94541
DEVICE: REXEED SERIES DIALYZERS ASAHI KASEI MEDICAL CO., LTD. 510(k) NO: K051187(SPECIAL) ATTN: DAVID L WEST PHONE NO : 301-272-3113 1801 ROCKVILLE PIKE, SUITE 300 SE DECISION MADE: 08-JUN-05 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLPUR DIALYZER, MODEL HD 190 NEPHROS, INC. 510(k) NO: K050603(TRADITIONAL) ATTN: NADIA C GREENIDGE PHONE NO : 212-781-5113 3960 BROADWAY SE DECISION MADE: 09-JUN-05 NEW YORK, NY 10032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 RENAL SOLUTIONS, INC. 510(k) NO: K043574(TRADITIONAL) ATTN: RICHARD CONFER PHONE NO : 724-772-6900 700 COMMONWEALTH DR SUITE 101 SE DECISION MADE: 03-JUN-05 WARRENDALE, PA 15086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERIM DIALYSATE MONITOR TEST STRIP SERIM RESEARCH CORP. 510(k) NO: K043031(TRADITIONAL) ATTN: PATRICIA A RUPCHOCK PHONE NO : 574-264-3440 23565 REEDY DR. SE DECISION MADE: 13-JUN-05 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. 510(k) NO: K050525(TRADITIONAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 24-JUN-05 LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC. 510(k) NO: K050727(SPECIAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4746 439 SOUTH UNION ST. SE DECISION MADE: 13-JUN-05 SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA LAWRENCE, MA 01843
DEVICE: FRESENIUS ART HEMOADSORPTION SYSTEM FRESENIUS MEDICAL CARE NORTH AMERI 510(k) NO: K050273(TRADITIONAL) ATTN: JANET KAY PHONE NO : 781-402-9068 95 HAYDEN AVE. SE DECISION MADE: 08-JUN-05 LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTI GAMBRO RENAL PRODUCTS 510(k) NO: K043342(TRADITIONAL) ATTN: KAE MILLER PHONE NO : 303-542-5045 10810 WEST COLLINS AVE. SE DECISION MADE: 27-MAY-05 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM DIALYSIS SERVICES, INC. 510(k) NO: K043344(TRADITIONAL) ATTN: MIKE STERLING PHONE NO : 615-384-4810 3620 KELTON JACKSON RD. SE DECISION MADE: 23-MAR-05 SPRINGFIELD, TN 37172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS LIBERTY CYCLER FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K043363(TRADITIONAL) ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068 95 HAYDEN AVE. SE DECISION MADE: 31-MAR-05 LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS GAMBRO RENAL PRODUCTS 510(k) NO: K042797(ABBREVIATED) ATTN: ROD J RYLANDS PHONE NO : 303-542-5075 10810 WEST COLLINS AVE. SE DECISION MADE: 09-MAR-05 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 NXSTAGE MEDICAL, INC. 510(k) NO: K043436(TRADITIONAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION ST. SE DECISION MADE: 17-MAR-05 SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA LAWRENCE, MA 01843
DEVICE: 14F DUAL FLOATING DIALYSIS CATHETER/TRAY CARDIOMED SUPPLIES, INC. 510(k) NO: K042672(TRADITIONAL) ATTN: CHRISTIAN G DUBE PHONE NO : 905 888 1965 5 GORMLEY INDUSTRIAL AVENUE SE DECISION MADE: 23-MAR-05 GORMLEY, ONTARIO, CANADA L0H 1G0 510(k) STATEMENT
DEVICE: GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS[/b] GAMBRO RENAL PRODUCTS 510(k) NO: K042938(SPECIAL) ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094 10810 WEST COLLINS AVE. SE DECISION MADE: 06-JAN-05 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
