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

    STERILE FIELD #605 FENESTRATED STERILE FIELD #606

    K Number: K864111 · Decision Oct 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    9
    Review Days
    9

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    Basic Information

    Device Name
    STERILE FIELD #605 FENESTRATED STERILE FIELD #606
    K Number
    K864111
    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
    October 21, 1986
    Decision Date
    October 30, 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 Graham Medical Products

    K Number Device Name
    K921657 VASECTOMY DRAPE
    K922100 DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE
    K922059 DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599
    K913447 DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599
    K913448 DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE
    K913560 STOPCOCK
    K903726 DRAPE, SURGICAL - UTILITY DRAPE - STERILE
    K863981 STERILIZATION WRAPS #620,624,648,640,636,630,612