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

    BROADLINE OR TOWELS

    K Number: K991667 · Decision Sep 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    2
    Review Days
    136

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    Basic Information

    Device Name
    BROADLINE OR TOWELS
    K Number
    K991667
    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
    Broadline Medical Industries
    Date Received
    May 14, 1999
    Decision Date
    September 27, 1999
    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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    Other Clearances by Broadline Medical Industries

    K Number Device Name
    K990584 GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE