BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    INTERA SHIELD AND INTERA UNDERGARMENT

    K Number: K885185 · Decision Feb 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    417
    Registration Numbers
    418
    Same Product Code
    55
    Applicant Total
    6
    Review Days
    56

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    Basic Information

    Device Name
    INTERA SHIELD AND INTERA UNDERGARMENT
    K Number
    K885185
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5920
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Intera Corp.
    Date Received
    December 14, 1988
    Decision Date
    February 8, 1989
    Product Code
    EYQ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EYQ Garment, Protective, For Incontinence

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    Other Clearances by Intera Corp.

    K Number Device Name
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    K863732 SURGICAL DRAPE & DRAPE ACCESSORIES
    K862380 MATTRESS COVER