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

    AT EASE STRESS PAD

    K Number: K880454 · Decision Jun 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    417
    Registration Numbers
    418
    Same Product Code
    55
    Applicant Total
    7
    Review Days
    135

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    Basic Information

    Device Name
    AT EASE STRESS PAD
    K Number
    K880454
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5920
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Hospital Specialty Co.
    Date Received
    February 2, 1988
    Decision Date
    June 16, 1988
    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 Hospital Specialty Co.

    K Number Device Name
    K990861 WOUND DRESSING/ABD PAD, MODEL #10810
    K941099 CLEAN-SORB
    K882094 GARDS DEODORANT SANITARY NAPKIN
    K880455 AT EASE ADULT DIAPER
    K822242 SANITARY/OB NAPKINS
    K822433 GARDS (UNSCENTED, MENSTRUAL PAD)