2008 HEMODIALYSIS SORBENT SYSTEM— 510(k) K093362
Substantially EquivalentRenal Solutions, Inc.
FDA 510(k) clearance K093362 for 2008 HEMODIALYSIS SORBENT SYSTEM, Substantially Equivalent on 2010-08-13. Applicant: Renal Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Renal Solutions, Inc.
- Product code
- Code FKT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5600
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Warrendale, PA, US
Recent devices under product code FKT
view allMore clearances from Renal Solutions, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.