BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PARAMED PARAFFIN WARMER

    K Number: K991427 · Decision Aug 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    112

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    Basic Information

    Device Name
    PARAMED PARAFFIN WARMER
    K Number
    K991427
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5110
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Divi Intl. Co.
    Date Received
    April 23, 1999
    Decision Date
    August 13, 1999
    Product Code
    IMC
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IMC Bath, Paraffin

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