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

    ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE

    K Number: K860246 · Decision Apr 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    0
    Applicant Total
    111
    Review Days
    68

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    Basic Information

    Device Name
    ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE
    K Number
    K860246
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Buckman Co., Inc.
    Date Received
    January 24, 1986
    Decision Date
    April 2, 1986
    Product Code
    PUP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PUP Endoscope Maintenance System

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