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

    CURAD KID SIZE INSTANT COLD PACK

    K Number: K920252 · Decision Feb 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    377
    Registration Numbers
    377
    Same Product Code
    81
    Applicant Total
    66
    Review Days
    21

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    Basic Information

    Device Name
    CURAD KID SIZE INSTANT COLD PACK
    K Number
    K920252
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    January 21, 1992
    Decision Date
    February 11, 1992
    Product Code
    IMD
    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
    IMD Pack, Hot Or Cold, Disposable

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