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

    ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX

    K Number: K000442 · Decision Apr 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    6
    Review Days
    439

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    Basic Information

    Device Name
    ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
    K Number
    K000442
    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
    Medical Concepts Development, Inc.
    Date Received
    February 10, 2000
    Decision Date
    April 24, 2001
    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 Medical Concepts Development, Inc.

    K Number Device Name
    K020581 COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
    K924794 TRANSPARENT ADHESIVE DRESSING
    K870044 MCD SPECIALTY BRAND NEEDLE COUNTERS
    K861530 SURGICAL PACKS, KITS AND TRAYS
    K861531 DISPOSABLE SURGICAL DRAPES AND ACCESSORIES