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

    HISTOFREEZER

    K Number: K931299 · Decision Aug 11, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    250
    Applicant Total
    28
    Review Days
    149

    Basic Information

    Device Name
    HISTOFREEZER
    K Number
    K931299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SOLARCARE TECHNOLOGIES CORP,INC.
    Date Received
    March 15, 1993
    Decision Date
    August 11, 1993
    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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