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

    DACOMED SNAP-GAUGE

    K Number: K832121 · Decision Jul 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    20
    Review Days
    18

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    Basic Information

    Device Name
    DACOMED SNAP-GAUGE
    K Number
    K832121
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Dacomed Corp.
    Date Received
    June 30, 1983
    Decision Date
    July 18, 1983
    Product Code
    LIL
    Advisory Committee
    Unknown
    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
    LIL Monitor, Penile Tumescence

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