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

    SURGICAL PACKS, KITS AND TRAYS

    K Number: K861530 · Decision May 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    6
    Review Days
    36

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    Basic Information

    Device Name
    SURGICAL PACKS, KITS AND TRAYS
    K Number
    K861530
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Medical Concepts Development, Inc.
    Date Received
    April 24, 1986
    Decision Date
    May 30, 1986
    Product Code
    FSM
    Advisory Committee
    General, Plastic Surgery
    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
    FSM Tray, Surgical, Instrument

    Similar 510(k) Clearances

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    INSTRUMENT TRAY LINER

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    SINGLE USE INSTRUMENT TRAY

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    SURGICAL INSTRUMENT TRAY

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    FDA Class 1 ·General, Plastic Surgery

    ARTHROSCOPY TRAY

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    OPEN HEART TRAY

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    HEART CATH TRAY

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    Other Clearances by Medical Concepts Development, Inc.

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    K020581 COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
    K000442 ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
    K924794 TRANSPARENT ADHESIVE DRESSING
    K870044 MCD SPECIALTY BRAND NEEDLE COUNTERS
    K861531 DISPOSABLE SURGICAL DRAPES AND ACCESSORIES