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

    IMPERVIOUS ISOLATION SHOE COVERS

    K Number: K923187 · Decision Jan 29, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    213

    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
    IMPERVIOUS ISOLATION SHOE COVERS
    K Number
    K923187
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dynatech Medical Products
    Date Received
    June 30, 1992
    Decision Date
    January 29, 1993
    Product Code
    FXW
    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
    FXW Shoes, Operating-Room

    Other Clearances by Dynatech Medical Products

    K Number Device Name
    K923188 DYNASTY IMPERVIOUS ISOLATION J-SUIT
    K922234 DYNASTY ISOLATION GOWN
    K893520 DR. BOO LATEX EXAMINATION GLOVES
    K770730 PUMP, INFUSION, DYNATECH/HANDLEY