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

    OLYMPUS SPRAY CATHETER PW-6C-1

    K Number: K012073 · Decision Aug 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    22
    Review Days
    39

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    Basic Information

    Device Name
    OLYMPUS SPRAY CATHETER PW-6C-1
    K Number
    K012073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Olympus Optical Co.
    Date Received
    July 2, 2001
    Decision Date
    August 10, 2001
    Product Code
    EOQ
    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
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by The Olympus Optical Co.

    K Number Device Name
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    K023272 DISPOSABLE ASPIRATION NEEDLE NA-200H
    K023767 UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES
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