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

    BOUNDARY SINGLE-USE CRANIOTOMY SHEET

    K Number: K820758 · Decision Apr 29, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    18
    Review Days
    38

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    Basic Information

    Device Name
    BOUNDARY SINGLE-USE CRANIOTOMY SHEET
    K Number
    K820758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    The Buckeye Cellulose Corp.
    Date Received
    March 22, 1982
    Decision Date
    April 29, 1982
    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 The Buckeye Cellulose Corp.

    K Number Device Name
    K822925 BOUNDARY SINGLE-USE GOWNS
    K823173 ARRIRM SCRUB BRUSH/SPONGE
    K821564 BOUNDARY PROCESS CHANGE
    K820116 BOUNDARY
    K813450 BOUNDARY SINGLE-USE DRAPES
    K813390 BONDARY SINGLE-USE OR GOWN
    K813277 BOUNDARY DRAPE TAPE
    K813263 PATIENT UNDERPAD
    K812962 BOUNDARY SURGICAL DRAPE
    K812738 BOUNDARY PROCESS CHANGE
    Search all 18 clearances from The Buckeye Cellulose Corp. →