BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇳 India

    Nulife

    K Number: K210969 · Decision Nov 3, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    1
    Review Days
    217

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    Basic Information

    Device Name
    Nulife
    K Number
    K210969
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mrk Healthcare Pvt, Ltd.
    Date Received
    March 31, 2021
    Decision Date
    November 3, 2021
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KGO Surgeon'S Gloves

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