Sentimag System, Sentimark Magnetic Marker Systerm— 510(k) K153044

Name: FDA 510(k) clearance K153044
Creator: U.S. Food and Drug Administration
Published: 2016-03-02

Substantially Equivalent

Endomagnetics Ltd.,

FDA 510(k) clearance K153044 for Sentimag System, Sentimark Magnetic Marker Systerm, Substantially Equivalent on 2016-03-02. Applicant: Endomagnetics Ltd.,. Device class: 2.

Clearance details

Applicant: Endomagnetics Ltd.,
Product code: Code PBY
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2015-10-19
Decision date: 2016-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, GB

Download summary PDF View on FDA.gov ↗

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