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

    LAC-MAC INNERBLOC O.R. GOWN

    K Number: K061491 · Decision Aug 9, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    6
    Review Days
    70

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    Basic Information

    Device Name
    LAC-MAC INNERBLOC O.R. GOWN
    K Number
    K061491
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lac Mac, Ltd.
    Date Received
    May 31, 2006
    Decision Date
    August 9, 2006
    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 Lac Mac, Ltd.

    K Number Device Name
    K102864 84E SERIES SINGLE PLY WRAPPER
    K092344 LAC-MAC INNERBLOC LR SURGICAL GOWNS
    K032631 INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)
    K031362 LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS
    K030536 LAC-MAC LIMITED INNERBLOC O.R. GOWN