BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DERMA PREP

    K Number: K851612 · Decision May 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    15

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DERMA PREP
    K Number
    K851612
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4380
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Mowbray Co., Inc.
    Date Received
    April 18, 1985
    Decision Date
    May 3, 1985
    Product Code
    KGT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGT Drape, Adhesive, Aerosol