SHILEY ARTERIAL FILTER W/40 MICRON SCREE— 510(k) K812742

Name: FDA 510(k) clearance K812742
Creator: U.S. Food and Drug Administration
Published: 1981-11-02

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K812742 for SHILEY ARTERIAL FILTER W/40 MICRON SCREE, Substantially Equivalent on 1981-11-02. Applicant: Shiley, Inc.. Device class: 2.

Clearance details

Applicant: Shiley, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1981-09-29
Decision date: 1981-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.