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

    MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN

    K Number: K091178 · Decision Jul 31, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    14
    Applicant Total
    10
    Review Days
    100

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    Basic Information

    Device Name
    MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN
    K Number
    K091178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mtp Medical Technical Promotion GmbH
    Date Received
    April 22, 2009
    Decision Date
    July 31, 2009
    Product Code
    MMP
    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
    MMP Cover, Barrier, Protective

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