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

    BAUER & BLACK ARM SLING W/DETACH. POUCH

    K Number: K803212 · Decision Jan 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    333
    Registration Numbers
    333
    Same Product Code
    18
    Applicant Total
    632
    Review Days
    22

    Basic Information

    Device Name
    BAUER & BLACK ARM SLING W/DETACH. POUCH
    K Number
    K803212
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3640
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Received
    December 17, 1980
    Decision Date
    January 8, 1981
    Product Code
    ILI
    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
    ILI Sling, Arm

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