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

    P.A. MEDICAL VAGINAL IRRIGATION SET #1130

    K Number: K854595 · Decision Jan 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    11
    Applicant Total
    5
    Review Days
    56

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    Basic Information

    Device Name
    P.A. MEDICAL VAGINAL IRRIGATION SET #1130
    K Number
    K854595
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.5900
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Pa Medical Corp.
    Date Received
    November 18, 1985
    Decision Date
    January 13, 1986
    Product Code
    HED
    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
    HED Douche Apparatus, Vaginal, Therapeutic

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    Other Clearances by Pa Medical Corp.

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