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FDA 510(k), K043342, POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
FDA 510(k), K043342, POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
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510(K) Number: K043342
Device Name: POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
Manufacturer: KAE MILLER
Device Classification Name: Dialyzer, Capillary, Hollow Fiber
Regulation Number: FJI
Classification Product Code: 12/06/2004
Date Received: 05/27/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
Manufacturer: KAE MILLER
Device Classification Name: Dialyzer, Capillary, Hollow Fiber
Regulation Number: FJI
Classification Product Code: 12/06/2004
Date Received: 05/27/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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