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

    SURGICAL DRAPE

    K Number: K910084 · Decision Mar 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    SURGICAL DRAPE
    K Number
    K910084
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Biocor Medical, Inc.
    Date Received
    January 8, 1991
    Decision Date
    March 19, 1991
    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 Biocor Medical, Inc.

    K Number Device Name
    K902293 ANGIOGRAPHY DRAPE PACK