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FDA 510(k), K082414, OPTIFLUX F250NR, MODEL 0500325E
FDA 510(k), K082414, OPTIFLUX F250NR, MODEL 0500325E
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$149.00 USD
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510(K) Number: K082414
Device Name: OPTIFLUX F250NR, MODEL 0500325E
Manufacturer: FRESENIUS MEDICAL CARE NORTH AMERICA
Device Classification Name: dialyzer, high permeability with or without sealed dialysate system
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 08/21/2008
Decision Date: 10/28/2008
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: OPTIFLUX F250NR, MODEL 0500325E
Manufacturer: FRESENIUS MEDICAL CARE NORTH AMERICA
Device Classification Name: dialyzer, high permeability with or without sealed dialysate system
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 08/21/2008
Decision Date: 10/28/2008
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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.
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