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

    L.A.F. ISOLATION PACK

    K Number: K802885 · Decision Jan 15, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    2
    Review Days
    59

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    Basic Information

    Device Name
    L.A.F. ISOLATION PACK
    K Number
    K802885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Action Medical Systems, Inc.
    Date Received
    November 17, 1980
    Decision Date
    January 15, 1981
    Product Code
    FYA
    Advisory Committee
    General, Plastic Surgery
    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
    FYA Gown, Surgical

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    Other Clearances by Action Medical Systems, Inc.

    K Number Device Name
    K830089 BURN DRESSING