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510(k) Data Aggregation

    K Number
    K030693
    Device Name
    KENTEX DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    KENTRON HEALTH CARE, INC.
    Date Cleared
    2003-08-27

    (175 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENTRON HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INTENDED TO BE USED FOR GENERAL THE UNGINA PROCEDURES. IT is INSERTED INTO THE VAGINA TRUCTOURES THE INTERioR OF THE VAGINA.
    Device Description
    Not Found
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    K Number
    K971917
    Device Name
    KENTRON'S ISOLATION GOWN
    Manufacturer
    KENTRON HEALTH CARE, INC.
    Date Cleared
    1997-09-19

    (119 days)

    Product Code
    FYC
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENTRON HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be worn to protect both the patient and healthcare personnel from transfer of micro-organisms, body fluids and particulate material.
    Device Description
    ISOLATION GOWN
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    K Number
    K972410
    Device Name
    IMPERVIOUS ISOLATION GOWN
    Manufacturer
    KENTRON HEALTH CARE, INC.
    Date Cleared
    1997-09-19

    (85 days)

    Product Code
    FYC
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENTRON HEALTH CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be worn to protect both the patient and healthcare personnel from transfer of micro-organisms, body fluids and particulate material.
    Device Description
    Imprevious Isolation Gown
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