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

    NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY

    K Number: K130995 · Decision Jun 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    6
    Review Days
    65

    Basic Information

    Device Name
    NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
    K Number
    K130995
    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
    Nuance Medical, LLC
    Date Received
    April 10, 2013
    Decision Date
    June 14, 2013
    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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