K970700
Substantially EquivalentFRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
- Applicant
- Fresenius USA, Inc.
- Product code
- MSE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut Creek, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.