BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    UNNA-SLEEVE(TM)

    K Number: K903532 · Decision Nov 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    UNNA-SLEEVE(TM)
    K Number
    K903532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Aci Medical, Inc.
    Date Received
    August 6, 1990
    Decision Date
    November 2, 1990
    Product Code
    LLK
    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
    LLK Legging, Compression, Non-Inflatable

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