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

    BOUNDARY

    K Number: K820116 · Decision Feb 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    18
    Review Days
    36

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    Basic Information

    Device Name
    BOUNDARY
    K Number
    K820116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    The Buckeye Cellulose Corp.
    Date Received
    January 18, 1982
    Decision Date
    February 23, 1982
    Product Code
    FYA
    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
    FYA Gown, Surgical

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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
    K820758 BOUNDARY SINGLE-USE CRANIOTOMY SHEET
    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. →