BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SOOTHIES GEL PADS

    K Number: K052858 · Decision Feb 9, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    121

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    Basic Information

    Device Name
    SOOTHIES GEL PADS
    K Number
    K052858
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5630
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Puronxy, Inc.
    Date Received
    October 11, 2005
    Decision Date
    February 9, 2006
    Product Code
    NXH
    Advisory Committee
    General Hospital
    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
    NXH Nursing Pad, Cohesive Gel