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

    CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit

    K Number: K210310 · Decision Oct 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    6
    Review Days
    261

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    Basic Information

    Device Name
    CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
    K Number
    K210310
    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
    February 3, 2021
    Decision Date
    October 22, 2021
    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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