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

    DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226

    K Number: K031697 · Decision Aug 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226
    K Number
    K031697
    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
    Schering-Plough Healthcare Products, Inc.
    Date Received
    June 2, 2003
    Decision Date
    August 29, 2003
    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 Schering-Plough Healthcare Products, Inc.

    K Number Device Name
    K052259 DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406