NEUTRON THERAPY SYSTEM— 510(k) K063691

Name: FDA 510(k) clearance K063691
Creator: U.S. Food and Drug Administration
Published: 2007-01-31

Substantially Equivalent

Northern Illinois Univ. Outreach

FDA 510(k) clearance K063691 for NEUTRON THERAPY SYSTEM, Substantially Equivalent on 2007-01-31. Applicant: Northern Illinois Univ. Outreach. Device class: 2.

Clearance details

Applicant: Northern Illinois Univ. Outreach
Product code: Code IWL
Device class: Class 2
Regulation: 21 CFR 892.5300
Advisory panel: Radiology
Date received: 2006-12-12
Decision date: 2007-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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