BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    SENTIO MMG Pedicle Access Needles

    K Number: K173134 · Decision Mar 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    34
    Applicant Total
    96
    Review Days
    174

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    Basic Information

    Device Name
    SENTIO MMG Pedicle Access Needles
    K Number
    K173134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medos International SARL
    Date Received
    September 29, 2017
    Decision Date
    March 22, 2018
    Product Code
    PDQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PDQ Neurosurgical Nerve Locator

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