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

    MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM

    K Number: K050347 · Decision Feb 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    22
    Review Days
    14

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    Basic Information

    Device Name
    MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
    K Number
    K050347
    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
    Endocare, Inc.
    Date Received
    February 11, 2005
    Decision Date
    February 25, 2005
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    RA
    Third Party
    Y

    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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