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

    BOUNDARY STERILIZATION WRAP

    K Number: K811819 · Decision Aug 4, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    18
    Review Days
    36

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    Basic Information

    Device Name
    BOUNDARY STERILIZATION WRAP
    K Number
    K811819
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    The Buckeye Cellulose Corp.
    Date Received
    June 29, 1981
    Decision Date
    August 4, 1981
    Product Code
    FRG
    Advisory Committee
    General Hospital
    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
    FRG Wrap, Sterilization

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    K820116 BOUNDARY
    K813450 BOUNDARY SINGLE-USE DRAPES
    K813390 BONDARY SINGLE-USE OR GOWN
    K813277 BOUNDARY DRAPE TAPE
    K813263 PATIENT UNDERPAD
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