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

    SUPER SILIPLUGS EAR PLUGS

    K Number: K972923 · Decision Oct 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    SUPER SILIPLUGS EAR PLUGS
    K Number
    K972923
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Interview Medical Technology Corp.
    Date Received
    August 8, 1997
    Decision Date
    October 27, 1997
    Product Code
    EWD
    Advisory Committee
    Unknown
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EWD Protector, Hearing (Insert)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EWD), ordered by most recent decision date.

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    HEARSAVER

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    FDA Unclassified ·Unknown

    THE VIRTUAL M-332

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    FDA Unclassified ·Unknown

    DOC'S PROPLUGS EAR PLUGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    MODEL 322 CLINICAL AUDIOMETER

    FDA 510(k)
    FDA Unclassified ·Unknown
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    Other Clearances by Interview Medical Technology Corp.

    K Number Device Name
    K972922 VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K