1
/
of
0
FDA 510(k), K080964, FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
FDA 510(k), K080964, FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
Regular price
$89.00 USD
Regular price
Sale price
$89.00 USD
Unit price
/
per
510(K) Number: K080964
Device Name: FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
Manufacturer: JANET C KAY
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 04/04/2008
Decision Date: 01/14/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
Manufacturer: JANET C KAY
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 04/04/2008
Decision Date: 01/14/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details