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

    FRIGIDERM FRIGISPRAY

    K Number: K971216 · Decision May 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    FRIGIDERM FRIGISPRAY
    K Number
    K971216
    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
    Dermatologic Lab & Supply, Inc.
    Date Received
    April 2, 1997
    Decision Date
    May 29, 1997
    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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    Other Clearances by Dermatologic Lab & Supply, Inc.

    K Number Device Name
    K010025 ELECTRICATOR MODEL 26000