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

    NONWOVEN SURGICAL DRAPE PACK

    K Number: K862062 · Decision Jun 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    7
    Review Days
    11

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    Basic Information

    Device Name
    NONWOVEN SURGICAL DRAPE PACK
    K Number
    K862062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    East Texas Lighthouse For the Blind
    Date Received
    May 30, 1986
    Decision Date
    June 10, 1986
    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 East Texas Lighthouse For the Blind

    K Number Device Name
    K883376 STERILIZATION WRAP TYPE 22,44,77
    K882275 STERILE PACK (PROCEDURAL TRAY/KITS)
    K863733 TOWEL PACK, SURGICAL
    K850067 MEDICAL, DISPOSABLE BEDDING
    K850811 PAD, PRE-OPERATIVE PREPARATION
    K850016 TOWEL PACK, SURGICAL