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

    R1363 PARAFFIN

    K Number: K861346 · Decision May 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    11
    Applicant Total
    35
    Review Days
    25

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    Basic Information

    Device Name
    R1363 PARAFFIN
    K Number
    K861346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5110
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Tri W-G, Inc.
    Date Received
    April 7, 1986
    Decision Date
    May 2, 1986
    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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