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

    CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.

    K Number: K896724 · Decision Jan 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    6
    Review Days
    41

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    Basic Information

    Device Name
    CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.
    K Number
    K896724
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Stiefel Research Institute, Inc.
    Date Received
    November 29, 1989
    Decision Date
    January 9, 1990
    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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