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

    THE ASSISTANT

    K Number: K952841 · Decision Aug 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    10
    Applicant Total
    9
    Review Days
    58

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    Basic Information

    Device Name
    THE ASSISTANT
    K Number
    K952841
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5160
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Apple Medical Corp.
    Date Received
    June 21, 1995
    Decision Date
    August 18, 1995
    Product Code
    FHA
    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
    FHA Clamp, Penile

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