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510(k) Data Aggregation

    K Number
    K001404
    Device Name
    GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    2000-08-08

    (97 days)

    Product Code
    ETA
    Regulation Number
    874.3495
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDNET LOCATOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001406
    Device Name
    HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    2000-08-08

    (97 days)

    Product Code
    ETA
    Regulation Number
    874.3495
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDNET LOCATOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K974174
    Device Name
    ULTRABUR
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1998-03-10

    (124 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDNET LOCATOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedNet LOCATOR, INC., ULTRABUR is to be used by ear, nose and throat physicians for forming a hole in the footplate for the placement of middle ear prostheses in stapedectomy procedures.
    Device Description
    ULTRABUR (Pheumatic Surgical Drill, Surgical Drill and Bur)
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    K Number
    K972734
    Device Name
    PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1997-09-05

    (45 days)

    Product Code
    ETB
    Regulation Number
    874.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDNET LOCATOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedNet Locator, INC., Partial Ossicular Replacement Prosthesis (PORP) is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.
    Device Description
    Partial Ossicular Replacement Prosthesis (PORP)
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    K Number
    K972735
    Device Name
    TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1997-09-05

    (45 days)

    Product Code
    ETA
    Regulation Number
    874.3495
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDNET LOCATOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedNet LocaTOR, INC., Total Ossicular Replacement Prosthesis (TORP) is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.
    Device Description
    Total Ossicular Replacement Prosthesis (TORP)
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    K Number
    K972737
    Device Name
    CAUSSE PISTON
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1997-09-05

    (45 days)

    Product Code
    ETB
    Regulation Number
    874.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDNET LOCATOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedNet Locator, INC., Piston Prosthesis is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.
    Device Description
    Piston Prosthesis
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    K Number
    K972126
    Device Name
    MYRINGOTOMY TUBE
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1997-07-29

    (54 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDNET LOCATOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedNet LOCATOR, INC., pediatric myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.
    Device Description
    Myringotomy Tube - Pediatric
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    K Number
    K971943
    Device Name
    MYRINGOTOMY TUBE
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1997-07-23

    (57 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDNET LOCATOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedNet LOCATOR, INC., bobbin myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.
    Device Description
    Myringotomy Tube - Bobbin
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    K Number
    K972400
    Device Name
    MYRINGOTOMY TUBE - BOBBIN WITH TAB
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1997-07-23

    (48 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDNET LOCATOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedNet Locator, INC., bobbin with tab myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.
    Device Description
    Myringotomy Tube - Bobbin with Tab
    Ask a Question

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