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

    LASER GAS MIXTURES

    K Number: K820535 · Decision Mar 31, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    23
    Applicant Total
    69
    Review Days
    29

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LASER GAS MIXTURES
    K Number
    K820535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Union Carbide Corp.
    Date Received
    March 2, 1982
    Decision Date
    March 31, 1982
    Product Code
    EWG
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EWG Laser, Ent Microsurgical Carbon-Dioxide

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EWG), ordered by most recent decision date.

    BENSON CCA100

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LASERMATIC SURGILASER MODEL 5050

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ILLUMINA 55 CO2 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ILLUMINA 40 CO2 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ILLUMINA 25 CO2 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Union Carbide Corp.

    K Number Device Name
    K830337 MARK III OXYGEN WALKER SYS-LOW PRESS
    K820836 MARK III OXYGEN WALKER SYSTEM
    K812536 LINDE MARK II
    K810732 LINDE MARK II OXYGEN RESERV. TYPE OR-4
    K810596 CENTRIFI CHEM SYSTEM 400 ANALYZER
    K810129 CENTRIFICHEM SYSTEM 500
    K803216 CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
    K802741 CENTRIFICHEM COMB. SERUM-BASED CALIB.
    K802520 CENTRIFICHEM PIPETTOR ACCURACY CALIB.
    K802420 CENTRIFICHEM INORGANIC PHOSPHORUS
    Search all 69 clearances from Union Carbide Corp. →