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

    CryoLab

    K Number: K190407 · Decision Apr 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    8
    Review Days
    60

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    Basic Information

    Device Name
    CryoLab
    K Number
    K190407
    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
    Cryoconcepts LP
    Date Received
    February 21, 2019
    Decision Date
    April 22, 2019
    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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    K240106 Histofreezer V
    K211099 Freeze’n Clear Skin Clinic Warts & Tags
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