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

    SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09

    K Number: K023540 · Decision Feb 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    105

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    Basic Information

    Device Name
    SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09
    K Number
    K023540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Valumed
    Date Received
    October 22, 2002
    Decision Date
    February 4, 2003
    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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    Other Clearances by Valumed

    K Number Device Name
    K023539 STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW