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

    MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT

    K Number: K860277 · Decision May 6, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    23
    Applicant Total
    17
    Review Days
    99

    Basic Information

    Device Name
    MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT
    K Number
    K860277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    BRITT CORP., INC.
    Date Received
    January 27, 1986
    Decision Date
    May 6, 1986
    Product Code
    EWG
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    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

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