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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).

July 6, 2007 - The FDA has released the 510(k)s Final Decisions Rendered for June 2007. There are two related to dialysis:<blockquote>DEVICE: ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15F
ASH ACCESS TECHNOLOGY, INC.
510(k) NO: K070572(TRADITIONAL)
ATTN: ROLAND WINGER
PHONE NO : 765-742-4813
3601 SAGAMORE PKWY N SUITE B
SE DECISION MADE: 26-JUN-07
LAFAYETTE, IN 47904
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODE
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K071387(SPECIAL)
ATTN: JANET C KAY
PHONE NO : 781-699-4475
920 WINTER STREET
SE DECISION MADE: 15-JUN-07
WALTHAM, MA 02451
510(k) SUMMARY AVAILABLE FROM FDA
</blockquote>

February 9, 2007 - The FDA has released the 510(k)s Final Decisions Rendered for January 2007. There are two related to dialysis:<blockquote>DEVICE: GAMBRO QUICKSET BLOODLINES
GAMBRO RENAL PRODUCTS
510(k) NO: K063290(TRADITIONAL)
ATTN: THOMAS B DOWELL
PHONE NO : 303-231-4094
10810 WEST COLLINS AVE.
SE DECISION MADE: 30-JAN-07
LAKEWOOD, CO 80215
510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER
SPIRE BIOMEDICAL INC
510(k) NO: K063431(TRADITIONAL)
ATTN: SHEKHAR D NIMKAR
PHONE NO : 781-275-6001
ONE PATRIOTS PARK
SE DECISION MADE: 29-JAN-07
BEDFORD, MA 01730</blockquote>

This message has been edited. Last edited by: Leigh,
 
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