ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500— 510(k) K070739

Name: FDA 510(k) clearance K070739
Creator: U.S. Food and Drug Administration
Published: 2007-05-25

Substantially Equivalent

Renal Solutions, Inc.

FDA 510(k) clearance K070739 for ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500, Substantially Equivalent on 2007-05-25. 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: 2007-03-16
Decision date: 2007-05-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Warrendale, PA, US

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