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

    IRRIGATOR STAND

    K Number: K894891 · Decision Aug 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    19
    Applicant Total
    5
    Review Days
    22

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    Basic Information

    Device Name
    IRRIGATOR STAND
    K Number
    K894891
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Commercial Products & Engineering Co.
    Date Received
    August 1, 1989
    Decision Date
    August 23, 1989
    Product Code
    HDC
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HDC Tenaculum, Uterine

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    Other Clearances by Commercial Products & Engineering Co.

    K Number Device Name
    K884542 SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED
    K883463 HOSPITAL BED CLOTHING CRADLE
    K882333 FLOOR LIGHT
    K873545 PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT