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

    MULTIPLE, SURGICAL DRAPE PACK

    K Number: K911132 · Decision May 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    3
    Review Days
    53

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    Basic Information

    Device Name
    MULTIPLE, SURGICAL DRAPE PACK
    K Number
    K911132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Central Georgia Ancillary Health Systems
    Date Received
    March 14, 1991
    Decision Date
    May 6, 1991
    Product Code
    FZI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FZI Apparatus, Air Handling, Enclosure

    Similar 510(k) Clearances

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    Other Clearances by Central Georgia Ancillary Health Systems

    K Number Device Name
    K923798 SURGICAL GOWN PACK
    K911131 STERILE SURGICAL GOWN PACK