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510(k) Data Aggregation

    K Number
    K051610
    Device Name
    HANS HERMANN LAPAROSCOPES AND ACCESSORIES
    Manufacturer
    HANS HERMANN GMBH
    Date Cleared
    2005-07-29

    (42 days)

    Product Code
    GCJ, GEI
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANS HERMANN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laparosopes and accessories are intended for use in providing access to and visualization of organs, and canals to perform various diagnostic and therapeutic surgical procedures. The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow. The bipolar electrodes are use to coagulate and to remove or destroy tissue by the use of bipolar HF current.
    Device Description
    The Hans Hermann Laparoscopes and accessories consists of - uls Hermann Daparoped surgical instruments with and without monopolar high frequency connection - bipolar electrodes and accessories - - monopolar electrodes and accessories - - monopolar cicchrodos and accessories, Verres needles and suction-/irrigation systems, - several Endoscopes (Laparoscope, Arthroscope, Cystoscope) - - and a light cable - The body contact portions of the Laparoscopes and accessories are composed of The body comace stainless steel, PTFE, PEEK, several coatings, silicon and brass surgical grade stamicss stock, in medical devices for a wide range of chiromutin placer which is commonly of biocompatibility for human use at short term contact.
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    K Number
    K983535
    Device Name
    THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010
    Manufacturer
    HANS HERMANN GMBH
    Date Cleared
    1998-12-29

    (81 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANS HERMANN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hermann Titanium (Mini/Micro/Medium) plating systems are intended for maxillo-facial surgery. The various sizes are designed to accommodate osteosynthesis requirements in pediatric and adult patients. Medical Indications Fractures in maxillo-facial bones -
    Device Description
    The Titanium Miniplating System H12-10104 - H19-30302 The Titanium Microplating System H22-01990 - H29-30302 The Titanium Mediumplating System H32-06104 - H39-30302
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