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

    DRAPE, SURGICAL - UTILITY DRAPE - STERILE

    K Number: K903726 · Decision Aug 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    9
    Review Days
    11

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    Basic Information

    Device Name
    DRAPE, SURGICAL - UTILITY DRAPE - STERILE
    K Number
    K903726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Graham Medical Products
    Date Received
    August 16, 1990
    Decision Date
    August 27, 1990
    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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    K913447 DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599
    K913448 DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE
    K913560 STOPCOCK
    K863981 STERILIZATION WRAPS #620,624,648,640,636,630,612
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