SARTORIUS AQUASART SM 40035 - DIALYSATE SYS— 510(k) K850435

Name: FDA 510(k) clearance K850435
Creator: U.S. Food and Drug Administration
Published: 1985-06-04

Substantially Equivalent

Sartorius Filters, Inc.

FDA 510(k) clearance K850435 for SARTORIUS AQUASART SM 40035 - DIALYSATE SYS, Substantially Equivalent on 1985-06-04. Applicant: Sartorius Filters, Inc.. Device class: 2.

Clearance details

Applicant: Sartorius Filters, Inc.
Product code: Code FKR
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-02-04
Decision date: 1985-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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