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

    MODEL C2100-SERIES OPHTHALMIC CRYOPROBE

    K Number: K810409 · Decision Mar 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    94
    Review Days
    30

    Basic Information

    Device Name
    MODEL C2100-SERIES OPHTHALMIC CRYOPROBE
    K Number
    K810409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Valleylab, Inc.
    Date Received
    February 18, 1981
    Decision Date
    March 20, 1981
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEH Unit, Cryosurgical, Accessories

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