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

    IMC SURGICAL DRAPE

    K Number: K100208 · Decision Apr 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    11
    Review Days
    85

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    Basic Information

    Device Name
    IMC SURGICAL DRAPE
    K Number
    K100208
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Medsurg Connection
    Date Received
    January 25, 2010
    Decision Date
    April 20, 2010
    Product Code
    KKX
    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
    KKX Drape, Surgical, Antimicrobial

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    K100846 IMC SURGICAL FACE MASK
    K023808 IRRIGATION SETS
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