BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENDOSCOPES FOR SINUS SURGERY

    K Number: K874215 · Decision Jan 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    71
    Review Days
    80

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    Basic Information

    Device Name
    ENDOSCOPES FOR SINUS SURGERY
    K Number
    K874215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Richards Medical Co., Inc.
    Date Received
    October 16, 1987
    Decision Date
    January 4, 1988
    Product Code
    EOB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

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    Other Clearances by Richards Medical Co., Inc.

    K Number Device Name
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    K895241 INTRAMEDULLARY HIP SCREW
    K884824 TRICON-M TOTAL KNEE SYSTEM
    K896204 ZIRCONIA CERAMIC HEAD ADD'L SIZES
    K895242 PAPPAS TRI-FLANGE VENTILATION TUBE
    K893377 RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
    K885069 ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
    K892366 POROUS GENESIS STEMMED TIBIAL COMPONENT
    Search all 71 clearances from Richards Medical Co., Inc. →