SORB+HISORB+CARTRIDGE— 510(k) K031099

Substantially Equivalent

Renal Solutions, Inc.

FDA 510(k) clearance K031099 for SORB+HISORB+CARTRIDGE, Substantially Equivalent on 2003-09-17. 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: 2003-04-07
Decision date: 2003-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apollo, PA, US

Download summary PDF View on FDA.gov ↗

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