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

    SEAL-RITE SILICONE EAR PLUG

    K Number: K910177 · Decision Jun 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    160

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    Basic Information

    Device Name
    SEAL-RITE SILICONE EAR PLUG
    K Number
    K910177
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Flents Products Co., Inc.
    Date Received
    January 15, 1991
    Decision Date
    June 24, 1991
    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)

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    THE VIRTUAL M-332

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    Other Clearances by Flents Products Co., Inc.

    K Number Device Name
    K915739 #903 SILAFLEX II