BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400

    K Number: K983882 · Decision Mar 15, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    133

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    Basic Information

    Device Name
    MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400
    K Number
    K983882
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Medical Devices, Inc.
    Date Received
    November 2, 1998
    Decision Date
    March 15, 1999
    Product Code
    HXR
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HXR Spatula, Orthopedic

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    Other Clearances by Micro-Medical Devices, Inc.

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    K951894 ACCESS EXPANSION SYSTEM
    K945656 THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE
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    K936213 ARTHROSCOPES AND ACCESSORIES