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

    PROTECTOR, HEEL & ELBOW

    K Number: K770635 · Decision May 23, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    374
    Registration Numbers
    374
    Same Product Code
    22
    Applicant Total
    35
    Review Days
    49

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    Basic Information

    Device Name
    PROTECTOR, HEEL & ELBOW
    K Number
    K770635
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Tecnol New Jersey Wound Care, Inc.
    Date Received
    April 4, 1977
    Decision Date
    May 23, 1977
    Product Code
    FMP
    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
    FMP Protector, Skin Pressure

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