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

    SRI LP GOWN

    K Number: K080723 · Decision Nov 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    2
    Review Days
    246

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    Basic Information

    Device Name
    SRI LP GOWN
    K Number
    K080723
    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
    Sri/Surgical Express, Inc.
    Date Received
    March 12, 2008
    Decision Date
    November 13, 2008
    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 Sri/Surgical Express, Inc.

    K Number Device Name
    K023635 SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN