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

    CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH

    K Number: K845010 · Decision Jan 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    417
    Registration Numbers
    418
    Same Product Code
    55
    Applicant Total
    33
    Review Days
    20

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    Basic Information

    Device Name
    CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH
    K Number
    K845010
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5920
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Chesebrough-Pond'S U.S.A. Co.
    Date Received
    December 26, 1984
    Decision Date
    January 15, 1985
    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 Chesebrough-Pond'S U.S.A. Co.

    K Number Device Name
    K863866 RESPIRADYNE II(TM)
    K862803 CHESEBROUGH POND'S HYDROCOLLOID DRESSING
    K851383 BLISTERFILM TRANSPARENT DRESSING
    K851382 CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
    K851539 CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO
    K843567 KANGAROO NASOGASTRIC FEEDING TUBE
    K844186 CONTINENT STOMA SYSTEM & ACCESSORIES
    K844789 KANGAROO ACCESS II ENTERAL FEEDING CONTAINER
    K843128 FEMALE URINARY INCONTINENCE SYS
    K843140 ISOLATE ADHESIVE BANDAGE FOR DRY WOUND
    Search all 33 clearances from Chesebrough-Pond'S U.S.A. Co. →