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510(k) Data Aggregation

    K Number
    K003405
    Device Name
    ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
    Manufacturer
    HIGHLAND / MARIETTA, INC.
    Date Cleared
    2001-05-07

    (187 days)

    Product Code
    KNF
    Regulation Number
    884.4160
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HIGHLAND / MARIETTA, INC.

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

    Ask a specific question about this device

    K Number
    K003403
    Device Name
    ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
    Manufacturer
    HIGHLAND / MARIETTA, INC.
    Date Cleared
    2001-05-07

    (187 days)

    Product Code
    JOS
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HIGHLAND / MARIETTA, INC.

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

    Ask a specific question about this device

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