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FDA 510(k) Applications Submitted by TOM FOLDEN
FDA 510(k) Number
Submission Date
Device Name
Applicant
K970700
02/25/1997
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
FRESENIUS USA, INC.
K941460
03/25/1994
FRESENIUS BLOOD TEMPERATURE MONITOR
FRESENIUS USA, INC.
K961465
04/17/1996
2008H ON LINE CLEARANCE MONITOR
FRESENIUS USA, INC.
K961706
05/02/1996
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
FRESENIUS USA, INC.
K974090
10/29/1997
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
FRESENIUS MEDICAL CARE NORTH AMERICA
K955423
11/28/1995
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
FRESENIUS USA, INC.
K955762
12/18/1995
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
FRESENIUS USA, INC.
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