2008 HEMODIALYSIS SORBENT SYSTEM— 510(k) K123835
Substantially EquivalentRenal Solutions, Inc.
FDA 510(k) clearance K123835 for 2008 HEMODIALYSIS SORBENT SYSTEM, Substantially Equivalent on 2013-02-15. 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
- Special
- Location
- Warrendale, PA, US
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