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510(k) Data Aggregation

    K Number
    K020296
    Device Name
    ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
    Manufacturer
    APOTHECARY PRODUCTS, INC.
    Date Cleared
    2002-06-25

    (148 days)

    Product Code
    EWD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    EWD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adult Silicone Ear Plugs are used for protection from noise. This device is for adult use only.
    Device Description
    Adult Silicone Ear Plug
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    K Number
    K972923
    Device Name
    SUPER SILIPLUGS EAR PLUGS
    Manufacturer
    INTERVIEW MEDICAL TECHNOLOGY CORP.
    Date Cleared
    1997-10-27

    (80 days)

    Product Code
    EWD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    EWD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Super SiliPlugs™ Ear Plugs are used to block water from entering the ear canal.
    Device Description
    Super SiliPlugs™ Ear Plugs
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    K Number
    K971517
    Device Name
    SILICONE PUTTY EAR PLUGS
    Manufacturer
    BENTEC MEDICAL, INC.
    Date Cleared
    1997-06-02

    (38 days)

    Product Code
    EWD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    EWD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silicone Putty Ear Plugs are used to block water from entering the ear canal.
    Device Description
    Silicone Putty Ear Plugs
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    K Number
    K962292
    Device Name
    HEARSAVER
    Manufacturer
    EMTECH LABORATORIES
    Date Cleared
    1996-10-29

    (137 days)

    Product Code
    EWD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    EWD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960500
    Device Name
    THE VIRTUAL M-332
    Manufacturer
    VIRTUAL CORP.
    Date Cleared
    1996-04-03

    (61 days)

    Product Code
    EWD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    EWD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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