2008 HEMODIALYSIS SORBENT SYSTEM— 510(k) K123835

Substantially Equivalent

Renal Solutions, Inc.

FDA 510(k) clearance K123835 for 2008 HEMODIALYSIS SORBENT SYSTEM, Substantially Equivalent on 2013-02-15. Applicant: Renal Solutions, Inc..

Clearance details

Applicant: Renal Solutions, Inc.
Product code: Code FKT
Advisory panel: Gastroenterology, Urology
Date received: 2012-12-13
Decision date: 2013-02-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Warrendale, PA, US

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