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

    CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000

    K Number: K862509 · Decision Jul 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    7
    Applicant Total
    23
    Review Days
    22

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    Basic Information

    Device Name
    CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000
    K Number
    K862509
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4220
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Lifestream Int'L, Inc.
    Date Received
    July 1, 1986
    Decision Date
    July 23, 1986
    Product Code
    JDY
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JDY Evacuator, Vapor, Cement Monomer

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