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

    HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS

    K Number: K980739 · Decision May 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    30
    Review Days
    90

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    Basic Information

    Device Name
    HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS
    K Number
    K980739
    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
    OraSure Technologies, Inc.
    Date Received
    February 25, 1998
    Decision Date
    May 26, 1998
    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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