NOTOUCH BREASTSCAN— 510(k) K113259

Substantially Equivalent

Ue Lifesciences, Inc.

FDA 510(k) clearance K113259 for NOTOUCH BREASTSCAN, Substantially Equivalent on 2012-02-10. Applicant: Ue Lifesciences, Inc.. Device class: 1.

Clearance details

Applicant: Ue Lifesciences, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2011-11-04
Decision date: 2012-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chester Springs, PA, 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.