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

    VEIN-SHIELD

    K Number: K820759 · Decision May 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    53

    Basic Information

    Device Name
    VEIN-SHIELD
    K Number
    K820759
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5210
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pan-Tech Research, Inc.
    Date Received
    March 22, 1982
    Decision Date
    May 14, 1982
    Product Code
    KMK
    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
    KMK Device, Intravascular Catheter Securement

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