BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    WART FREEZE

    K Number: K101049 · Decision Jun 23, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    250
    Applicant Total
    2
    Review Days
    435

    Basic Information

    Device Name
    WART FREEZE
    K Number
    K101049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KONINKLIJKE UTERMOHLEN NV
    Date Received
    April 14, 2010
    Decision Date
    June 23, 2011
    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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    Other Clearances by KONINKLIJKE UTERMOHLEN NV

    K Number Device Name
    K130599 WART FREEZE