2008 HEMODIALYSIS SORBENT SYSTEM— 510(k) K093362

Substantially Equivalent

Renal Solutions, Inc.

FDA 510(k) clearance K093362 for 2008 HEMODIALYSIS SORBENT SYSTEM, Substantially Equivalent on 2010-08-13. Applicant: Renal Solutions, Inc..

Clearance details

Applicant: Renal Solutions, Inc.
Product code: Code FKT
Advisory panel: Gastroenterology, Urology
Date received: 2009-10-28
Decision date: 2010-08-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Warrendale, PA, US

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