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

    AMNIPERF(TM)

    K Number: K926425 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    439

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    Basic Information

    Device Name
    AMNIPERF(TM)
    K Number
    K926425
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Raymart Development Co.
    Date Received
    December 23, 1992
    Decision Date
    March 7, 1994
    Product Code
    HGE
    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
    HGE Amniotome

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