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

    DEROYAL INDUSTRIES INFANT HEEL WARMER

    K Number: K954716 · Decision Jan 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    10
    Applicant Total
    4
    Review Days
    90

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    Basic Information

    Device Name
    DEROYAL INDUSTRIES INFANT HEEL WARMER
    K Number
    K954716
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Debusk Knitting Mills, Div. Deroyal Industries
    Date Received
    October 13, 1995
    Decision Date
    January 11, 1996
    Product Code
    MPO
    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
    MPO Infant Heel Warmer (Chemical Heat Pack)

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    Other Clearances by Debusk Knitting Mills, Div. Deroyal Industries

    K Number Device Name
    K961097 ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
    K961085 DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING
    K961087 DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS