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

    ERBECRYO 2 Cryosurgical Unit with accessories

    K Number: K151041 · Decision May 4, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    39
    Review Days
    14

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    Basic Information

    Device Name
    ERBECRYO 2 Cryosurgical Unit with accessories
    K Number
    K151041
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Erbe USA, Inc.
    Date Received
    April 20, 2015
    Decision Date
    May 4, 2015
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    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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