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

    BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO

    K Number: K790877 · Decision May 23, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    16

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    Basic Information

    Device Name
    BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO
    K Number
    K790877
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4220
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Stackhouse Assoc.
    Date Received
    May 7, 1979
    Decision Date
    May 23, 1979
    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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    LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER

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    CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000

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    MASK, VAPOR, MONOMER

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    Other Clearances by Stackhouse Assoc.

    K Number Device Name
    K912651 AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM
    K910515 FREEDOM MARK III SURGICAL HELMET SYSTEM
    K874512 MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM
    K872935 ANTI-INFECTION SHIELD