BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TRANSPARENT ADHESIVE DRESSING

    K Number: K924794 · Decision Jul 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    972
    Registration Numbers
    972
    Same Product Code
    186
    Applicant Total
    6
    Review Days
    288

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    Basic Information

    Device Name
    TRANSPARENT ADHESIVE DRESSING
    K Number
    K924794
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Concepts Development, Inc.
    Date Received
    September 23, 1992
    Decision Date
    July 8, 1993
    Product Code
    KGX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGX Tape And Bandage, Adhesive

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    Other Clearances by Medical Concepts Development, Inc.

    K Number Device Name
    K020581 COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
    K000442 ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
    K870044 MCD SPECIALTY BRAND NEEDLE COUNTERS
    K861530 SURGICAL PACKS, KITS AND TRAYS
    K861531 DISPOSABLE SURGICAL DRAPES AND ACCESSORIES