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

    STERILE O. R. TOWEL

    K Number: K861928 · Decision Jun 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    44
    Review Days
    20

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    Basic Information

    Device Name
    STERILE O. R. TOWEL
    K Number
    K861928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Anago, Inc.
    Date Received
    May 20, 1986
    Decision Date
    June 9, 1986
    Product Code
    IXX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IXX Processor, Cine Film

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