FDA 510(k), K083460, DIALOG WITH ADIMEA OPTION
FDA 510(k), K083460, DIALOG WITH ADIMEA OPTION
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$149.00 USD
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510(K) Number: K083460
Device Name: DIALOG WITH ADIMEA OPTION
Manufacturer: BONNIE KINCAID, RAC
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 11/21/2008
Date Received: 02/18/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: DIALOG WITH ADIMEA OPTION
Manufacturer: BONNIE KINCAID, RAC
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 11/21/2008
Date Received: 02/18/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology