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

    LL100 CRYOSURGICAL SYSTEM

    K Number: K803311 · Decision Feb 4, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    27
    Review Days
    33

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    Basic Information

    Device Name
    LL100 CRYOSURGICAL SYSTEM
    K Number
    K803311
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Wallach Surgical Devices, Inc.
    Date Received
    January 2, 1981
    Decision Date
    February 4, 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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